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Clinical Trial Results:
A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate Efficacy, Pharmacokinetics, Safety, and Tolerability of Treatment With JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)ide Analog With or Without JNJ-56136379 in Treatment-naïve Patients With HBeAg Positive Chronic Hepatitis B Virus Infection

Summary
EudraCT number	2019-004978-26
Trial protocol	GB FR DE
Global end of trial date	12 Feb 2024

Results information
Results version number	v1(current)
This version publication date	17 Apr 2025
First version publication date	17 Apr 2025
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

73763989PAHPB2005

ISRCTN number

US NCT number

NCT04439539

WHO universal trial number (UTN)

Sponsor organisation name

Janssen Research & Development, LLC

Sponsor organisation address

920 Route 202, Raritan, United States, 08869

Public contact

Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com

Scientific contact

Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

12 Feb 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

12 Feb 2024

Was the trial ended prematurely?

Main objective of the trial

The main objective of the study was to assess the efficacy of a treatment regimen of JNJ-73763989 (JNJ-3989) plus pegylated interferon alpha-2a (PegIFN-alpha-2a) plus nucleos(t)ide analog (NA: tenofovir disoproxil [TDF]/tenofovir alafenamide [TAF]).

Protection of trial subjects

This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.

Background therapy

Evidence for comparator

Actual start date of recruitment

15 Oct 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Canada: 7

Country: Number of subjects enrolled

Germany: 2

Country: Number of subjects enrolled

Spain: 8

Country: Number of subjects enrolled

France: 6

Country: Number of subjects enrolled

United Kingdom: 5

Country: Number of subjects enrolled

Japan: 4

Country: Number of subjects enrolled

Russian Federation: 10

Country: Number of subjects enrolled

Türkiye: 9

Country: Number of subjects enrolled

Taiwan: 2

Country: Number of subjects enrolled

United States: 1

Worldwide total number of subjects

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The Study consisted of 3 phases: induction phase (IP), consolidation phase (CP) and follow-up (FU) phase. Response-guided treatment (RGT): hepatitis B (HB) surface antigen (HBsAg) less than(<) 10 international unit per millilitre (IU/mL ) and RGT was removed post protocol amanedment 5 (PA 5).

Screening details

Nucleos(t)ide (NA) treatment completion criteria: HBsAg <10 IU/mL, HB envelop antigen (HBeAg)-negative, HB virus deoxyribonucleic acid (HBV DNA) <lower limit of quantification (LLOQ) and alanine aminotransferase (ALT) <3*upper limit of normal (ULN).

Period 1 title

IP:Day 1-Week 36(post-PA5)/52(prior-PA5)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a

Arm description

Prior to PA 5, in IP, enrolled participants received JNJ-3989 200 milligrams (mg) subcutaneous (SC) injection once every 4 weeks (Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD for >=36 to <=52 weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week CP and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Post PA 5, participant not reached IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit. Per PA 6, JNJ-6379 treatment was stopped. Post CP Week 12, participants entered 48-week FU phase and stopped JNJ-3989+PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.

Arm type

Experimental

Investigational medicinal product name

JNJ-73763989

Investigational medicinal product code

JNJ-73763989

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received JNJ-3989 200 mg SC injection Q4W for >=36-weeks (post PA 5) to <=52-weeks (prior to PA 5)

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAF 25 mg tablet orally QD for up to >=36-weeks (post PA 5) to <=52-weeks (prior to PA 5)

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAD 245 mg tablet orally QD for up to >=36-weeks (post PA 5) to <=52-weeks (prior to PA 5)

Investigational medicinal product name

JNJ-56136379

Investigational medicinal product code

JNJ-56136379

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received JNJ-6379 250 mg tablet orally QD for >=36-weeks (post PA 5) to <=52-weeks (prior to PA 5)

Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a

Arm description

Per PA 5, in the IP, enrolled participants received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD for 36 weeks. After completion of IP Week 36, participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, participants entered the 48-week FU phase and stopped treatment withJNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if completion criteria was not met, NA was continued till the end of FU phase.

Arm type

Experimental

Investigational medicinal product name

JNJ-73763989

Investigational medicinal product code

JNJ-73763989

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received JNJ-3989 200 mg SC injection Q4W for 36 weeks.

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAF 25 mg tablet orally QD for 36 weeks.

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAD 245 mg tablet orally QD for 36 weeks.

Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a

Arm description

In the IP, participants enrolled as per PA 6 received JNJ-3989 200 mg SC injection Q4W plus NA (TDF 245 mg/TAF 25 mg) tablet orally QD for 36 weeks. After completion of IP Week 36, participants entered 12-week CP during which PegIFN-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if completion criteria was not met, NA was continued till the end of FU phase.

Arm type

Experimental

Investigational medicinal product name

JNJ-73763989

Investigational medicinal product code

JNJ-73763989

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received JNJ-3989 200 mg SC injection Q4W for 36 weeks.

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAF 25 mg tablet orally QD for 36 weeks.

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAD 245 mg tablet orally QD for 36 weeks.

Number of subjects in period 1	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a
Started	27	8	19
Completed	26	8	17
Not completed	1	0	2
Consent withdrawn by subject	1	-	2

Period 2 title

CP Phase: CP Week 1 to 12

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a

Arm description

Arm type

Experimental

Investigational medicinal product name

JNJ-73763989

Investigational medicinal product code

JNJ-73763989

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received JNJ-3989 200 mg SC injection Q4W from CP Week 1 to 12.

Investigational medicinal product name

JNJ-56136379

Investigational medicinal product code

JNJ-56136379

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received JNJ-6379 250 mg tablet orally QD from CP Week 1 to 12.

Investigational medicinal product name

pegylated interferon alpha-2a

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received PegIFN-alpha-2a 180 mcg SC injection QW from IP Week 36 for 12 weeks. Those who passed IP W36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a from their next visit up to CP Week 12.

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAF 25 mg tablet orally QD from CP Week 1 to 12.

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAD 245 mg tablet orally QD from CP Week 1 to 12.

Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a

Arm description

Arm type

Experimental

Investigational medicinal product name

JNJ-73763989

Investigational medicinal product code

JNJ-73763989

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received JNJ-3989 200 mg SC injection Q4W from CP Week 1 to 12.

Investigational medicinal product name

pegylated interferon alpha-2a

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAF 25 mg tablet orally QD from CP Week 1 to 12.

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAD 245 mg tablet orally QD from CP Week 1 to 12.

Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a

Arm description

Arm type

Experimental

Investigational medicinal product name

JNJ-73763989

Investigational medicinal product code

JNJ-73763989

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Participants received JNJ-3989 200 mg SC injection Q4W from CP Week 1 to 12.

Investigational medicinal product name

pegylated interferon alpha-2a

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAF 25 mg tablet orally QD from CP Week 1 to 12.

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAD 245 mg tablet orally QD from CP Week 1 to 12.

Number of subjects in period 2	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a
Started	26	8	17
Subjects actually started CP	25 ^[1]	7 ^[2]	17
Completed	26	8	17

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: One participant discontinued JNJ-3989 treatment due to treatment failure/relapse and moved directly from IP to FU phase without CP.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: One participant discontinued JNJ-3989 treatment due to treatment failure/relapse and moved directly from IP to FU phase without CP.

Period 3 title

FU Phase: FU Week 1 to 48

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a

Arm description

Arm type

Experimental

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TAF 25 mg tablet orally QD up to FU Week 2. If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU Week 2. If NA completion criteria was not met, NA was continued till the end of FU phase (FU Week 48).

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received TDF 245 mg tablet orally QD up to FU Week 2. If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU Week 2. If NA completion criteria was not met, NA was continued till the end of FU phase (FU Week 48).

Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a

Arm description

Arm type

Experimental

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a

Arm description

Arm type

Experimental

Investigational medicinal product name

Tenofovir alafenamide

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Investigational medicinal product name

Tenofovir disoproxil

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Number of subjects in period 3	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a
Started	26	8	17
Completed	26	6	17
Not completed	0	2	0
Consent withdrawn by subject	-	1	-
Unspecified	-	1	-

Baseline characteristics

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Reporting group title

Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a

Reporting group description

Reporting group values	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a	Total
Number of subjects	27	8	19
Age Categorical
Units: Subjects
Age continuous
Units: years
arithmetic mean (standard deviation)	35.6 ( 9.95 )	27.3 ( 9.95 )	33.6 ( 11.15 )	-
Gender categorical
Units: Subjects
Male	12	5	11	28
Female	15	3	8	26

End points

Top of page

Reporting group title

Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a

Reporting group description

Subject analysis set title

Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

Prior PA 5, participants received JNJ-3989 200 mg SC injection 4th weekly(Q4W) + JNJ-6379 250 mg tablets orally once daily (QD) + NA (TDF 245 mg/TAF 25 mg) tablet orally QD in IP for >=36 to <=60 weeks. Participants who met RGT criterion or reached 60 weeks were considered completed IP & entered 12 week CP & randomized to JNJ-3989 200 mg SC injection Q4W + JNJ-6379 250 mg tablets orally QD + NA (TDF 245 mg/TAF 25 mg) tablet orally QD or JNJ-3989 200 mg SC injection Q4W + JNJ-6379 250 mg tablets orally QD + NA (TDF 245 mg/TAF 25 mg) tablets orally QD + PegIFN-alpha-2a 180 mcg SC injection QW. Post PA 5, participants not reached IP Week (W)36, started PegINF-alpha-2a at W36 for 12 weeks & who passed IP W36 &/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at next visit. Per PA 6 JNJ-6379 treatment discontinued. Post 12 week CP, participants entered 48 week FU phase till FU Week 48 & stopped JNJ-3989 + PegIFN-alpha-2a.

Subject analysis set title

Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

Per PA 5, participants in IP received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablets orally QD for 36 weeks. After completion of IP W36, all participants entered 12-week CP during which PegINF-alpha-2a 180 mcg SC injection QW was added to their treatment regimen for 12-weeks. After completion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment withJNJ-3989 plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP W12 NA was stopped at FU W2, if completion criteria was not met NAwas continued till the end of FU phase.

Subject analysis set title

Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

Participants enrolled as per PA 6 received JNJ-3989 200 mg SC injection for Q4W plus NA (tenofovir disoproxil 245 mg/tenofovir alafenamide 25 mg) tablet orally QD for 36 weeks in IP. After completion of IP, participants entered 12-week CP and received PegIFN-alpha-2a 180 mcg QW for 12-week. Aftcompletion of 12-week CP, all participants entered the 48-week FU phase and stopped treatment with JNJ-3989 plus NA plus PegIFN-alpha-2a. If NA treatment completion criteria was met at CP W12 NA was stopped at FU W2, if completion criteria was not met NA was continued till the end of FU phase

Subject analysis set title

IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

Prior to PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD in IP for a RGT duration for >=36-weeks to <=52-weeks.

Subject analysis set title

IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

Per PA 5, participants received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for 36 weeks.

Subject analysis set title

IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

Participants enrolled as per PA 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.

Subject analysis set title

CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

After completion of IP, participants entered in 12 week CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TAD 250 mg or TAF 25 mg) tablet orally QD from CP Week 1 to 12 and PegIFN-alpha-2a 180 mcg SC injection was added to their treatment regimen from IP Week 36 for 12 weeks.

Subject analysis set title

CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

After completion of IP, participants entered in 12-week CP and received JNJ-3989 200 mg SC injection Q4W + NA (TDF 245 mg/TAF 25 mg) tablets orally QD from CP Week 1 to 12 and PegIFN-alpha2a 180 mcg SC QW was added to their treatment regimen from IP Week 36 for 12 weeks.

Subject analysis set title

CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12 NA was stopped at FU W2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.

Subject analysis set title

FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

After completion of CP, all participants entered 48-Week FU phase and stopped treatment with JNJ-3989 plus NA (TAD 245 mg/TAF 25 mg) plus PegIFN-alpha2a. If NA treatment completion criteria was met at CP Week 12, NA treatment was stopped at FU Week 2, if NA treatment completion criteria was not met, NA (TAD 245 mg/TAF 25 mg) was continued till the end of FU phase.

Subject analysis set title

FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Induction phase

Subject analysis set type

Per protocol

Subject analysis set description

Prior PA 5, participants received JNJ-3989 200 mg SC injection for Q4W + JNJ-6379 250 mg tablets orally QD plus NA (TAD 245 mg/TAF 25 mg) tablet orally QD for >=36-weeks to <=52-weeks. Participants who met RGT criterion/reached 52 weeks were considered to complete IP and entered 12-week CP and randomized to JNJ-3989 + JNJ-6379 + NA or JNJ-3989+JNJ-6379 + NA + PegIFN-alpha-2a 180 micrograms (mcg) SC injection once weekly (QW). Per PA 5, participants received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD for 36 weeks. Participants enrolled as per PA 6, received JNJ-3989 200 mg SC for Q4W plus NA (either tenofovir disoproxil 250 mg or 25 mg tenofovir alafenamide) tablet orally QD for 36 weeks in IP. Post PA 5, participant not reached IP Week 36, started PegINF-alpha-2a at Week 36 for 12 weeks and who passed IP Week 36 and/or were randomized to CP without PegINF-alpha-2a, started pegINF-alpha-2a at their next visit.

Subject analysis set title

Consolidation phase

Subject analysis set type

Per protocol

Subject analysis set description

After completion of IP, participants entered the 12 weeks CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TDF 245 mg/TAF 25 mg) tablet orally QD plus PegIFN-alpha-2a 180 mcg SC QW. At the end of the CP, all participants entered the 48-weeks follow-up (FU) phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA plus PegIFN-alpha-2a.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase. If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.

Subject analysis set title

Induction phase

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Consolidation phase

Subject analysis set type

Per protocol

Subject analysis set description

After completion of IP, participants entered the 12 weeks CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TDF 245 mg/TAF 25 mg) tablet orally QD plus PegIFN-alpha-2a 180 mcg SC QW. At the end of the CP, all participants entered the 48-weeks follow-up (FU) phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA plus PegIFN-alpha-2a.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.

Subject analysis set title

Induction phase

Subject analysis set type

Per protocol

Subject analysis set description

Subject analysis set title

Consolidation phase

Subject analysis set type

Per protocol

Subject analysis set description

After completion of IP, participants entered the 12 weeks CP and received JNJ-3989 200 mg SC Q4W plus JNJ-6379 250 tablets QD plus NA (either TDF 245 mg/TAF 25 mg) tablet orally QD plus PegIFN-alpha-2a 180 mcg SC QW. At the end of the CP, all participants entered the 48-weeks follow-up (FU) phase and stopped treatment with JNJ-3989 plus JNJ-6379 plus NA plus PegIFN-alpha-2a.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.If NA treatment completion criteria was met at CP Week 12, NA was stopped at FU phase Week 2, if not met, NA was continued till end of FU phase.

Primary: Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping all Study Interventions at the end of Consolidation Phase (CP) and Without Restarting Nucleos(t)ide analog (NA) Treatment

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End point title

Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping all Study Interventions at the end of Consolidation Phase (CP) and Without Restarting Nucleos(t)ide analog (NA) Treatment ^[1]

End point description

Percentage of participants with functional cure (defined as percentage of participants with HBsAg seroclearance at 24 weeks after stopping all study interventions at end of CP and without restarting NA treatment) were reported. Seroclearance of HBsAg was defined as a (quantitative) HBsAg level less than (<) lower limit of quantification (LLOQ; 0.05 IU/mL). Per protocol analysis set: all randomised/enrolled participants who received at least 1 dose of CP study intervention and did not had any of the selected major protocol deviations that might affect the assessment of efficacy in terms of the primary endpoint at 24 weeks after stopping all study interventions of the CP.

End point type

Primary

End point timeframe

At follow-up (FU) phase Week 24

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No inferential statistics was done. Only descriptive statistics was performed.

End point values	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a
Number of subjects analysed	26	8	17
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

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End point title

Number of Participants with Treatment Emergent Adverse Events (TEAEs)

End point description

Number of participants with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment. Safety analysis set (SAS) included all participants who received at least one dose of study intervention. Participants were analysed according to the study intervention they actually received.

End point type

Secondary

End point timeframe

IP: From Day 1 up to end of IP (up to Week 36 per PA 5; up to Week 52 prior to PA 5); CP: CP Week 1 up to CP Week 12; FU phase: FU Week 1 up to FU Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25 ^[2]	7 ^[3]	17	26 ^[4]	8 ^[5]	17
Units: participants	22	8	15	22	7	13	17	5	11

Notes
[2] - 1 participant who moved directly from IP to FU was not counted in this arm.
[3] - 1 participant who moved directly from IP to FU was not counted in this arm.
[4] - 25 participants from CP + 1 participant moved directly from IP.
[5] - 7 participants from CP + 1 participant moved directly from IP.

No statistical analyses for this end point

Secondary: Number of Participants with Treatment Emergent Serious Adverse Events (TESAEs)

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End point title

Number of Participants with Treatment Emergent Serious Adverse Events (TESAEs)

End point description

Number of participants with TESAEs were reported. An AE was any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the study intervention. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are all AEs with an onset on or after the first administration of study treatment or any ongoing event that worsened in severity, intensity or frequency after the first administration of study treatment. Safety analysis set included all participants who received at least one dose of study intervention. Participants were analysed according to the study intervention they actually received.

End point type

Secondary

End point timeframe

IP: From Day 1 up to end of IP (up to Week 36 per PA 5; up to Week 52 prior to PA 5); CP: CP Week 1 up to CP Week 12; FU phase: FU Week 1 up to FU Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25	7	17	26	8	17
Units: participants	0	0	0	0	0	0	0	0	1

No statistical analyses for this end point

Secondary: Number of Participants with Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests

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End point title

Number of Participants with Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests

End point description

Laboratory parameters: Hematology (Hem): absolute lymphocyte count, (ALC), A neutrophil count (ANC), hemoglobin (Hb) , Neutrophils Band Form (NBF) , Neutrophils segmented (Neu Seg), WBC decreased (dcrsd); Chem: alanine aminotransferase (ALT) & serum glutamic pyruvic transaminase (SGPT), aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT), cholesterol (CLSTRL) (fasting[F]), creatinine Kinase (Cr Kin), Glomerular filtration rate (GFR) from Creatinine (Cr) Adjusted for body surface area ((Ad.BSA), GFR Cystatin (Cy) C (Ad. BSA), low-density lipoprotein (LDL: fasting[F]), triglycerides (Tglrds[F]); Urinalysis: glycosuria. DAIDS toxicity grades: Grade (Gr) 1 (Mild), Gr 2 (Moderate), Gr 3 (Severe), Gr 4 (Potentially Life-Threatening). Here, number of participants with TE DAIDS toxicity Grade 3 or 4 were reported in this endpoint. SAS was analysed. n=0, and 99999 signify that data were not collected & analysed as timepoint was not applicable to respective arm.

End point type

Secondary

End point timeframe

IP: From Day 1 up to end of IP (up to Week 36 per PA 5; up to Week 52 prior to PA 5); CP: CP Week 1 up to CP Week 12; FU phase: FU Week 1 up to FU Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25	7	17	26	8	17
Units: participants
Hem:ALC:Low:Gr 3 :n=26,8,19, 25,7,17,26,8,17	0	0	0	1	0	0	0	0	0
Hem: ANC: Gr 3: n=26,8,19, 25,7,17,26,8,17	0	0	0	2	0	0	0	0	0
Hem: HB: Low: Gr 3 :n=26,8,19, 25,7,17,26,8,17	0	0	0	1	0	0	0	1	0
Hem: NBF: Low: Gr4:n=0,0,0,3,0,0,1,0,1	99999	99999	99999	3	99999	99999	1	99999	1
Hem:Neu Seg:Low:Gr3: n=26,8,19,25,7,17,26,8,17	0	0	0	2	0	0	0	0	0
Hem:WBC dcrsd:Low:Gr3:n=26,8,19,25,7,17,26,8,17	0	0	0	3	0	1	1	0	0
Chem:ALT/SGPT:High:Gr3:n=26,8,19,25,7,17,26,8,17	1	0	0	1	0	2	0	0	0
Chem:AST/SGOT:High:Gr3:n=26,8,19,25,7,17,26,8,17	0	0	0	0	0	1	0	0	0
Chem:CLSTRL(F):High:Gr3:n=26,8,19,25,7,17,26,8,17	1	0	0	1	0	0	1	0	0
Chem:Cr Kin:High:Gr3:n=26,8,19,25,7,17,26,8,17	0	0	0	0	0	2	0	0	0
Chem: Cr Kin:High:Gr4:n=26,8,19,25,7,17,26,8,17	1	0	0	0	0	0	0	0	0
Che:GFR:Cr Ad.BSA:L:Gr3:n=26,8,19,25,7,17,26,8,17	1	0	0	0	0	0	0	0	0
Che:GFR:Cyc Ad.BSA:L:Gr3:n=26,8,19,25,7,17,26,8,17	1	0	0	1	0	0	1	0	1
Che:GFR:Cyc Ad.BSA:L:Gr4:n=26,8,19,25,7,17,26,8,17	0	0	0	0	0	0	0	0	1
Chem:LDL(F):High:Gr3:n=26,8,19,25,7,17,26,8,17	2	0	0	1	0	1	0	0	0
Chem:Tglrds(F):High:Gr3:n=26,8,19,25,7,17,26,8,17	0	0	1	1	0	0	1	0	0
Urinalysis:Glycosuria:Gr3:n=17,7,7,13,6,6,12,8,5	0	0	0	0	0	0	0	1	0

No statistical analyses for this end point

Secondary: Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs)

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End point title

Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs)

End point description

Number of participants with worst treatment-emergent abnormality in ECG were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. ECG parameters included heart rate (HR; abnormally low, HR <45 beats per minute (bpm) and (abnormally high HR>=120 bpm; PR interval abnormally high >220 milliseconds (ms): QRS interval abnormally high >=120 ms; QT corrected (Fridericia QTcF) categories; borderline prolonged QTc interval <450 to <=480 ms), prolonged QTc interval <480 to <=500 ms) and pathologically prolonged QTc interval >500 ms). Safety analysis set included all participants who received at least one dose of study intervention. Participants were analysed according to the study intervention they actually received.

End point type

Secondary

End point timeframe

IP: From Day 1 up to end of IP (up to Week 36 per PA 5; up to Week 52 prior to PA 5); CP: CP Week 1 up to CP Week 12; FU phase: FU Week 1 up to FU Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25	7	17	26	8	17
Units: participants	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs

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End point title

Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs

End point description

Number of participants with worst treatment-emergent abnormalities in vital signs were reported. Treatment-emergent abnormality was defined as the abnormalities that were worsened as compared to the abnormality at baseline; which also included the shift from abnormally high to abnormally low and vice-versa. Abnormalities in vital signs included abnormal pulse rate (PR); abnormally low, <=45 bpm and abnormally high >=120 bpm; diastolic blood pressure (DBP) abnormally low <=50 mmHg, systolic blood pressure (SBP) abnormally low <=90 mmHg. Additionally, abnormal low SBP and DBP were <=50 mmHg and <+90 mmHg. Only those categories in which at least one participant had data were reported.

End point type

Secondary

End point timeframe

IP: From Day 1 up to end of IP (up to Week 36 per PA 5; up to Week 52 prior to PA 5); CP: CP Week 1 up to CP Week 12; FU phase: FU Week 1 up to FU Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	8	19	25	7	17	26	8	17
Units: participants
DBP: High:	3	1	1	1	0	1	1	1	0
SBP: Low	0	1	0	1	1	1	1	0	0
SBP: High	2	1	3	1	0	0	2	1	1
Pulse rate: High	0	1	0	0	0	1	0	0	0

No statistical analyses for this end point

Secondary: Number of Participants With Clinically Important Abnormalities in Physical Examination

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End point title

Number of Participants With Clinically Important Abnormalities in Physical Examination

End point description

Number of participants with clinically important abnormalities in physical examination were reported. Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analysed according to the study intervention they actually received.

End point type

Secondary

End point timeframe

IP: From Day 1 up to end of IP (up to Week 36 per PA 5; up to Week 52 prior to PA 5); CP: CP Week 1 up to CP Week 12; FU phase: FU Week 1 up to FU Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25	7	17	26	8	17
Units: participants	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)

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End point title

Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)

End point description

Percentage of participants who reached HBsAg <10 IU/mL at the end induction phase were reported. Treated analysis set included all participants who received at least 1 dose of study treatment within this Intervention-specific appendix (ISA). Here, "n"(number analysed) signifies participants who were evaluable at specified timepoints. Data for this endpoint were planned to be collected and analysed for IP only. Here, 99999 signifies that no participant was available for the analysis.

End point type

Secondary

End point timeframe

At IP Week 36 and EOI; anytime up to IP Week 36 (after PA 5) or up to IP Week 52 (prior to PA 5)

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a
Number of subjects analysed	26	7	19
Units: percentage of participants
number (not applicable)
IP Week 36 (n=13, 0, 1)	0	99999	10
End of Induction phase (n=26, 7, 19)	15.4	37.5	10.5

No statistical analyses for this end point

Secondary: Time to Achieve First Occurrence of HBsAg <10 IU/mL

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End point title

Time to Achieve First Occurrence of HBsAg <10 IU/mL

End point description

Time to achieve first occurrence of HBsAg <10 IU/mL]) were reported. Time to HBsAg <10 IU/mL was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg <10 IU/mL. Kaplan-Meier method was used for the estimation. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here, 99999 signifies that upper limit and lower limit of CI was not estimable due to insufficient number of participants with events.

End point type

Secondary

End point timeframe

From Baseline (Day 1 of IP) to Follow up Week 48

End point values	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19
Units: weeks
median (confidence interval 90%)	48.1 (-99999 to 99999)	84.3 (2.1 to 99999)	48.3 (36.1 to 99999)

No statistical analyses for this end point

Secondary: FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase

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End point title

FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase

End point description

Percentage of participants with HBsAg seroclearance 48 weeks after stopping all study interventions at the consolidation phase and without restarting NA treatment during follow up phase were reported. HBsAg seroclearance was defined as (quantitative) HBsAg < LLOQ (HBsAg 0.05 IU/mL). Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint.

End point type

Secondary

End point timeframe

FU phase Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	6	17
Units: percentage of participants
number (not applicable)	11.5	16.7	11.8

No statistical analyses for this end point

Secondary: FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase

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End point title

FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase

End point description

Percentage of participants with HBV DNA <LLOQ (<20 IU/mL) 48 weeks after stopping all study interventions of the consolidation phase and without restarting NA treatment during follow up phase were reported. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint. Here, N=0 signifies that data were not collected and analysed for participants who stopped NA at the end of treatment.

End point type

Secondary

End point timeframe

FU phase: FU Week 1 up to FU Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	0 ^[6]	0 ^[7]	1
Units: percentage of participants
number (not applicable)			0

Notes
[6] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment
[7] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment

No statistical analyses for this end point

Secondary: Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase

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End point title

Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase

End point description

Percentage of participants meeting the protocol-defined NA treatment completion criteria at EOC were reported. NA treatment completion criteria at CP Week 12 was defined as HBsAg <10 IU/mL; HBeAg-negative; HBV DNA <20 IU/mL, that is, lower limit of quantification (LLOQ); alanine aminotransferase(ALT) <3*ULN. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

At CP Week 12

End point values	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	25	7	16
Units: percentage of participants
number (not applicable)	0	0	5.9

No statistical analyses for this end point

Secondary: FU Phase: Number of Participants with Off-treatment Virologic HBV Flares During Follow up Phase

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End point title

FU Phase: Number of Participants with Off-treatment Virologic HBV Flares During Follow up Phase

End point description

Number of participants with off-treatment virologic HBV flares were reported. Virologic flare was defined as confirmed HBV DNA >peak threshold (lowest peak to qualify as virologic flare was HBV DNA >200 IU/mL) in participants who were off-treatment and had HBV DNA <LLOQ (<20 IU/mL) at the last observed time point on all study treatments. The 3 thresholds of virologic flare was 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA). Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint. Here, N=0 signifies that data were not collected and analysed for participants who stopped NA at the end of treatment.

End point type

Secondary

End point timeframe

FU phase: FU Week 1 up to FU Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	0 ^[8]	0 ^[9]	1
Units: participants			0

Notes
[8] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment
[9] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment

No statistical analyses for this end point

Secondary: FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase

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End point title

FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase

End point description

Number of participants with on-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST >=3*ULN and >=3*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. On-treatment was defined as the time period during which the participant received any of the study drugs. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.

End point type

Secondary

End point timeframe

FU phase: FU Week 1 up to FU Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	8	17
Units: participants	2	0	2

No statistical analyses for this end point

Secondary: FU Phase: Number of Participants with Off-treatment Biochemical HBV Flares During Follow-up Phase

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End point title

FU Phase: Number of Participants with Off-treatment Biochemical HBV Flares During Follow-up Phase

End point description

Number of participants with off-treatment biochemical HBV flares were reported. Biochemical flare was defined as first date of 2 consecutive visits with confirmed ALT and/or AST >=3*ULN and >=3*nadir (lowest value observed up to start of flare). Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. Off-treatment was defined as the time period after stopping all study treatments (including NA). Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint. Here, N=0 signifies that data were not collected and analysed for participants who stopped NA at the end of treatment.

End point type

Secondary

End point timeframe

FU phase: FU Week 1 up to FU Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	0 ^[10]	0 ^[11]	1
Units: participants			0

Notes
[10] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment
[11] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment

No statistical analyses for this end point

Secondary: FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase

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End point title

FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase

End point description

Clinical flares occurred either when a virologic flare (confirmed HBV DNA >peak threshold) & biochemical flare (ALT and/or AST >=3*ULN & >=3*nadir [lowest value observed during off-treatment period up to time point of meeting the flare criteria]) overlapped in time or when a biochemical flare started within 4 weeks following the end of a virologic flare. The HBV DNA thresholds were: 20,000 IU/mL, 2,000 IU/mL and 200 IU/mL. Confirmed means that criteria was fulfilled at 2 or more consecutive time points or at last observed time point. Off-treatment was defined as time period after stopping all study drugs (including NA). The start date of a clinical flare was minimum start date of virologic flare and biochemical flare. Treated analysis set was used. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint. Here, N=0 signifies that data were not collected and analysed for participants who stopped NA at the end of treatment.

End point type

Secondary

End point timeframe

FU phase: FU Week 1 up to FU Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	0 ^[12]	0 ^[13]	1
Units: participants			0

Notes
[12] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment
[13] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment

No statistical analyses for this end point

Secondary: FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase

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End point title

FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase

End point description

Percentage of participants who required NA re-treatment during follow-up phase were reported. A responder was defined as a participant who met the criteria for NA re-treatment at any time during follow-up, for those participants who met the NA treatment completion criteria at any time during the study and actually stopped NA treatment. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint. Here, N=0 signifies that data were not collected and analysed for participants who stopped NA at the end of treatment.

End point type

Secondary

End point timeframe

FU phase: FU Week 1 up to FU Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	0 ^[14]	0 ^[15]	1
Units: percentage of participants
number (not applicable)			0

Notes
[14] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment
[15] - N=0 signifies data were not collected & analysed for participants who stopped NA at end of treatment

No statistical analyses for this end point

Secondary: FU phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48

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End point title

FU phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48

End point description

Percentage of participants with sustained (reduction) HBsAg response (per Definition 1) were reported. Sustained HBsAg response (definition 1) was defined as: For participants with FU Week 48 data: participants who had a >1 log10 decline from baseline in HBsAg and HBsAg <000 IU/mL at FU Week 48. For participants without FU Week 48 data: participants who had a HBsAg decline from baseline of >2 log10 at FU Week 24 or >1.5 log10 at FU Week 36 (most recent value used) and had HBsAg <1000 IU/mL at the last available timepoint.

End point type

Secondary

End point timeframe

At FU Phase Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	7	17
Units: percentage of participants
number (not applicable)	53.85	57.1	70.6

No statistical analyses for this end point

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48

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End point title

Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48

End point description

Percentage of participants with sustained (reduction) HBsAg response (per definition 3) were reported. Sustained HBsAg response (per Definition 3) was defined as: for participants with a >1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was <0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was <0.2 and had an HBsAg <1000 IU/mL at the last available timepoint. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

At Follow up Phase Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	7	17
Units: percentage of participants
number (not applicable)	42.3	28.6	52.9

No statistical analyses for this end point

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48

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End point title

Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48

End point description

Percentage of participants with sustained (reduction) HBsAg response (per Definition 2) were reported. Sustained HBsAg response (per Definition 2) was defined as: for participants with a >1 log decline in HBsAg from baseline at last follow-up visit: Among the most recent three visits, the difference between log10 HBsAg at 2 of 3 last visit and 1 of 3 last visit was <0.2, and the difference between log10 HBsAg at 3 of 3 last visit and 1 of 3 last visit was <0.2. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

At FU Phase Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	7	17
Units: percentage of participants
number (not applicable)	65.4	42.9	70.6

No statistical analyses for this end point

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48

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End point title

Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48

End point description

Percentage of participants with sustained (reduction) HBsAg response per Definition 4 were reported. Sustained HBsAg response (per Definition 4) was defined as stable level, decreasing level, and increasing level. Stable level: when HBsAg change from consolidationweek 12 to last available follow-up timepoint was within 0.2 log10. Decreasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was less than -0.2 log10. Increasing level: when HBsAg change from consolidation week 12 to last available follow-up timepoint was more than 0.2 log10. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

At Follow up Phase Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	7	17
Units: percentage of participants
number (not applicable)
Stable: within +/-0.2 log10 IU/mL	0	14.3	11.8
Decreased: <0.2 log10 IU/mL	19.2	14.3	17.6
Increased: > +0.2 log10 IU/mL	76.9	71.4	70.6

No statistical analyses for this end point

Secondary: Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48

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End point title

Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48

End point description

Percentage of Participants with HBsAg Seroclearance were reported. HBsAg seroclearance was defined as (quantitative) HBsAg level <LLOQ (<0.05 IU/mL). Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint.

End point type

Secondary

End point timeframe

At Follow up Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	6	17
Units: percentage of participants
number (not applicable)	11.5	16.7	11.8

No statistical analyses for this end point

Secondary: Percentage of Participants with HBeAg Seroclearance at Follow-up Week 48

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End point title

Percentage of Participants with HBeAg Seroclearance at Follow-up Week 48

End point description

Percentage of participants with HBeAg seroclearance were reported. HBeAg seroclearance was defined as (quantitative) HBeAg levels <LLOQ (<0.11 IU/mL). Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint.

End point type

Secondary

End point timeframe

At Follow up Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	25	6	17
Units: percentage of participants
number (not applicable)	28.0	33.3	17.6

No statistical analyses for this end point

Secondary: Percentage of Participants with HBsAg Seroconversion

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End point title

Percentage of Participants with HBsAg Seroconversion

End point description

Seroconversion of HBsAg was defined as having achieved HBsAg seroclearance (defined as quantitative HBsAg <LLOQ [<0.05 IU/mL]) and appearance of anti-HBs antibodies (defined as a baseline anti-HBs antibodies [quantitative] <LLOQ [<5 milli-international units per milliliter (mIU/mL)] and a post-baseline assessment >=LLOQ [>=5 mIU/mL]). Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint and "n" (number analysed) signifies participants evaluable at specified timepoints and n=0, and 99999 signify that data were not collected and analysed as that timepoint was not applicable to the respective arm.

End point type

Secondary

End point timeframe

IP Week 24; CP: Week 12, FU phase: Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	25	7	15	24	6	15	25	7	15
Units: percentage of participants
number (not applicable)
IP: Week 24 (n=25, 7, 15, 0, 0, 0, 0, 0, 0)	0	0	0	99999	99999	99999	99999	99999	99999
CP: Week 12 (n=0, 0, 0, 24,6,15, 0, 0, 0)	99999	99999	99999	8.3	33.3	6.7	99999	99999	99999
FU phase Week 48 (n=0, 0, 0, 0, 0, 0, 25, 7, 15)	99999	99999	99999	99999	99999	99999	12.0	99999	6.7

No statistical analyses for this end point

Secondary: Percentage of Participants with HBeAg Seroconversion

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End point title

Percentage of Participants with HBeAg Seroconversion

End point description

Percentage of participants with HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (defined as [quantitative] HBeAg <LLOQ [<0.11 IU/mL]) together with appearance of anti-HBe antibodies (defined as a baseline anti-HBe antibodies [qualitative] with a "negative" result and a post-baseline assessment with “positive” result). Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Data were planned to be collected and analysed for CP and FU phase only. Here, n=0, and 99999 signify that data were not collected and analysed as that timepoint was not applicable to the respective arm.

End point type

Secondary

End point timeframe

CP: Week 12; FU phase: FU Week 48

End point values	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	21	6	11	22	7	11
Units: percentage of participants
number (not applicable)
CP: Week 12 (n=21, 6,11, 0, 0, 0)	0	16.7	9.1	99999	99999	99999
FU phase week 48 (n=0, 0, 0, 22, 7, 11)	99999	99999	99999	18.2	20.0	27.3

No statistical analyses for this end point

Secondary: Change from baseline over time in HBsAg Levels

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End point title

Change from baseline over time in HBsAg Levels

End point description

Change from baseline over time in HBsAg levels at specified timepoints were reported. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "n"(number analysed) signifies participants evaluable at specified timepoints. Here, 99999 at IP Week 36 category for Cohort 2 (Per PA 6) signifies that standard deviation was not estimable as only 1 participant was analysed. Here, n=0, and 99999 signify that data were not collected and analysed as that timepoint was not applicable to the respective arm.

End point type

Secondary

End point timeframe

Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25	7	17	26	6	17
Units: log10 IU/mL
arithmetic mean (standard error)
IP: Week 36 (n=13,0,1,0,0,0,0,0,0)	-2.29 ( 0.211 )	99999 ( 99999 )	-4.08 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
CP: Week 12(n=0,0,0,25,7,17,0,0,0)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-3.51 ( 0.275 )	-4.17 ( 0.444 )	-3.53 ( 0.285 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
FU phase: Week 48(n=0,0,0,0,0,0,26,8,17)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-2.41 ( 0.364 )	-3.14 ( 0.747 )	-2.82 ( 0.425 )

No statistical analyses for this end point

Secondary: Change from baseline over time in HBeAg Levels

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End point title

Change from baseline over time in HBeAg Levels

End point description

Change from baseline over time in HBeAg levels were reported. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, 99999 at IP Week 36 category for Cohort 2 (Per PA 6) signifies that standard deviation was not estimable as only 1 participant was analysed. Here, "n"=number of subjects analysed at specified categories n=0, and 99999 signify that data were not collected and analysed as that timepoint was not applicable to the respective arm.

End point type

Secondary

End point timeframe

Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	24	7	17	25	8	17
Units: log10 IU/mL
arithmetic mean (standard error)
IP: Week 36(n=12,0,1,0,0,0,0,0,0)	-1.66 ( 0.159 )	99999 ( 99999 )	-2.85 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
CP: Week 12(n=0,0,0,24,7,17,0,0,0)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-2.14 ( 0.146 )	-2.39 ( 0.162 )	-2.22 ( 0.234 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
FU phase: Week 48(n=0,0,0,0,0,0,25,8,17)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-2.45 ( 0.243 )	-2.59 ( 0.508 )	-2.47 ( 0.278 )

No statistical analyses for this end point

Secondary: Change from Baseline Over Time in HBV DNA Levels

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End point title

Change from Baseline Over Time in HBV DNA Levels

End point description

Change from baseline over time in HBV DNA Levels were reported. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this outcome measure and "n"(number analysed) signifies participants evaluable at specified timepoints. Here, 99999 at IP Week 36 category for Cohort 2 (Per PA 6) signifies that standard deviation was not estimable as only 1 participant was analysed. Here, "n"=number of subjects analysed at specified categories and n=0, and 99999 signify that data were not collected and analysed as that timepoint was not applicable to the respective arm.

End point type

Secondary

End point timeframe

Baseline (Day 1 of IP), IP: Week 36; CP: Week 12; FU phase: Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25	6	17	26	8	17
Units: log10 IU/mL
arithmetic mean (standard error)
IP: Week 36 (n=14,0,1,0,0,0,0,0,0)	-5.84 ( 0.427 )	99999 ( 99999 )	-6.99 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
CP: Week 12(n=0,0,0,25,6,17,0,0,0)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-6.29 ( 0.205 )	-6.30 ( 0.350 )	-6.07 ( 0.269 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
FU phase: Week 48(n=0,0,0,0,0,0,26,6,17)	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	-6.79 ( 0.203 )	-5.95 ( 0.563 )	-6.70 ( 0.257 )

No statistical analyses for this end point

Secondary: Time to Achieve First HBsAg Seroclearance

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End point title

Time to Achieve First HBsAg Seroclearance

End point description

Time to achieve first HBsAg seroclearance (defined as quantitative HBsAg <LLOQ; HBsAg <0.05 IU/mL) were reported. Time to HBsAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of HBsAg seroclearance. Kaplan-Meier method was used for the estimation. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint. Here, 99999 signifies that that median [90% CI] data were not estimable due to low number of events. Per planned analysis data for this outcome measure was analysed per pooled cohorts only.

End point type

Secondary

End point timeframe

From baseline (Day 1 of IP) to Follow up Week 48

End point values	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19
Units: weeks
median (confidence interval 90%)	99999 (99999 to 99999)	99999 (6.1 to 99999)	99999 (99999 to 99999)

No statistical analyses for this end point

Secondary: Time to Achieve First HBV DNA <LLOQ

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End point title

Time to Achieve First HBV DNA <LLOQ

End point description

Time to achieve first occurrence of HBV DNA < LLOQ (<20 IU/mL) were reported. Time to first occurrence of the HBV DNA < LLOQ was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBV DNA < LLOQ. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint. Per planned analysis data for this outcome measure was analysed per pooled cohorts only. Here 99999 signifies upper interval of [90% CI] data were not estimable due to low number of events.

End point type

Secondary

End point timeframe

From baseline (Day 1 of IP) to Follow up Week 48

End point values	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19
Units: weeks
median (confidence interval 90%)	35.9 (28.1 to 52.1)	53.3 (12.1 to 99999)	38.1 (24.1 to 50.1)

No statistical analyses for this end point

Secondary: Time to Achieve First HBeAg Seroclearance

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End point title

Time to Achieve First HBeAg Seroclearance

End point description

Time to achieve first occurrence of HBeAg seroclearance (HBeAg <LLOQ [<0.11 IU/mL]) were reported. Time to first occurrence of the HBeAg seroclearance was defined as the number of days between the date of first study intervention intake and the date of the first occurrence of the HBeAg seroclearance. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies participants who were evaluable for this endpoint. Per planned analysis data for this outcome measure was analysed per pooled cohorts only. Here, 99999 signifies that Median and upper interval of [90% CI] data were not estimable due to low number of events.

End point type

Secondary

End point timeframe

From baseline (Day 1 of IP) to Follow up Week 48

End point values	Cohort 1 (Prior PA 5): JNJ-3989+JNJ-6379+NA + PegIFN-alpha-2a	Cohort 1 (Per PA 5): JNJ-3989+ NA + PegIFN-alpha-2a	Cohort 2 (Per PA 6): JNJ-3989+ NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19
Units: weeks
median (confidence interval 90%)	112 (96.1 to 99999)	100.3 (48.0 to 99999)	99999 (59.1 to 99999)

No statistical analyses for this end point

Secondary: Percentage of participants with HBeAg Levels Below Different Cut-offs

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End point title

Percentage of participants with HBeAg Levels Below Different Cut-offs

End point description

Percentage of participants with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were : <LLOQ (<0.11 IU/mL), < 1 IU/mL, < 10 IU/mL, <100 IU/mL. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed)signifies participants who were evaluable for this endpoint. Here, n=0, and 99999 signify that data were not collected and analysed as that timepoint was not applicable to the respective arm.

End point type

Secondary

End point timeframe

IP: Week 36, CP: Week 12; FU phase: Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	26	8	19	24	7	17	25	8	17
Units: percentage of participants
number (not applicable)
IP Week 36: <0.11 IU/mL(n=12,0,1,0,0,0,0,0,0)	8.3	99999	0	99999	99999	99999	99999	99999	99999
IP Week 36: <1 IU/mL (n=12,0,1,0,0,0,0,0,0)	25.0	99999	0	99999	99999	99999	99999	99999	99999
IP Week 36: <10 IU/mL(n=12,0,1,0,0,0,0,0,0)	50.0	99999	100.0	99999	99999	99999	99999	99999	99999
IP Week 36: <100 IU/mL(n=12,0,1,0,0,0,0,0,0)	100.0	99999	100.0	99999	99999	99999	99999	99999	99999
CP Week 12: <0.11 IU/mL (n=0, 0, 0,24,7,17,0,0,0)	99999	99999	99999	12.5	14.3	17.6	99999	99999	99999
CP Week 12: <1 IU/mL(n=0, 0, 0,24,7,17,0,0,0)	99999	99999	99999	37.5	14.3	47.1	99999	99999	99999
CP Week 12: <10 IU/mL(n=0, 0, 0,24,7,17,0,0,0)	99999	99999	99999	75.0	100.0	76.5	99999	99999	99999
CP Week 12: <100 IU/mL(n=0, 0, 0,24,7,17,0,0,0)	99999	99999	99999	95.8	100.0	94.1	99999	99999	99999
FU Week 48: <0.11 IU/mL (n=0, 0, 0,0,0,0,25,6,17)	99999	99999	99999	99999	99999	99999	28.0	33.3	17.6
FU Week 48: <1 IU/mL(n=0, 0, 0,0,0,0,25,6,17)	99999	99999	99999	99999	99999	99999	44.0	50.0	52.9
FU Week 48: <10 IU/mL(n=0, 0, 0,0,0,0,25,6,17)	99999	99999	99999	99999	99999	99999	80.0	83.3	76.5
FU Week 48: <100IU/mL(n=0, 0, 0,0,0,0,25,6,17)	99999	99999	99999	99999	99999	99999	96.0	100	100

No statistical analyses for this end point

Secondary: Percentage of Participants With HBsAg Levels Below Different Cut-offs

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End point title

Percentage of Participants With HBsAg Levels Below Different Cut-offs

End point description

Percentage of participants with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg level were: <LLOQ (<0.05 IU/mL), <1 IU/mL, <10 IU/mL, <100 IU/mL, <1000 IU/mL. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here, "n"=number of subjects analysed at specified categories. n=0, and 99999 signify that data were not collected and analysed as that timepoint was not applicable to the respective arm.

End point type

Secondary

End point timeframe

IP: Week 36, CP: Week 12; FU phase: Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25	7	17	26	8	17
Units: percentage of participants
number (not applicable)
IP Week 36: <0.05 IU/mL(n=13,0,1,0,0,0,0,0,0)	0	99999	0	99999	99999	99999	99999	99999	99999
IP Week 36: <1 IU/mL(n=13,0,1,0,0,0,0,0,0)	0	99999	0	99999	99999	99999	99999	99999	99999
IP Week 36: <10 IU/mL(n=13,0,1,0,0,0,0,0,0)	0	99999	100.0	99999	99999	99999	99999	99999	99999
IP Week 36: <100 IU/mL(n=13,0,1,0,0,0,0,0,0)	23.1	99999	100.0	99999	99999	99999	99999	99999	99999
IP Week 36: <1000 IU/mL(n=13,0,1,0,0,00,0,0)	69.2	99999	100.0	99999	99999	99999	99999	99999	99999
CP Week 12: <0.05 IU/mL(n=0,0,0,25,7,17,0,0,0)	99999	99999	99999	8.0	42.9	5.9	99999	99999	99999
CP Week 12: <1 IU/mL(n=0,0,0,25,7,17,0,0,0)	99999	99999	99999	20.0	42.9	23.5	99999	99999	99999
CP Week 12: <10 IU/mL(n=0,0,0,25,7,17,0,0,0)	99999	99999	99999	40.0	42.9	47.1	99999	99999	99999
CP Week 12: <100 IU/mL(n=0,0,0,25,7,17,0,0,0)	99999	99999	99999	60.0	71.4	76.5	99999	99999	99999
CP Week 12: <1000 IU0/mL(n=0,0,0,25,7,17,0,0,0)	99999	99999	99999	100.0	100.0	94.1	99999	99999	99999
FU Week 48: <0.05 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999	99999	99999	99999	99999	99999	11.5	16.7	11.8
FU Week 48: <1 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999	99999	99999	99999	99999	99999	11.5	33.3	17.6
FU Week 48: <10 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999	99999	99999	99999	99999	99999	19.2	50.0	29.4
FU Week 48: <100 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999	99999	99999	99999	99999	99999	26.9	50.0	47.1
FU Week 48: <1000 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999	99999	99999	99999	99999	99999	57.7	66.7	76.5

No statistical analyses for this end point

Secondary: Percentage of Participants With HBV DNA Levels Below Different Cut-offs

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End point title

Percentage of Participants With HBV DNA Levels Below Different Cut-offs

End point description

Percentage of participants with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as follows: <LLOQ (<20 IU/mL) for target detected or not detected(Td and Nd), < LLOQ for target not detected (TNd), and < LLOQ for target detected (TD), <60 IU/mL, <100 IU/mL, <200 IU/mL, <1000 IU/mL, <2000 IU/mL, <20000 IU/mL. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here, "n"(number of participants analysed) signifies participants analysed at specified categories. Here, n=0, and 99999 signify that data were not collected and analysed as that timepoint was not applicable to the respective arm.

End point type

Secondary

End point timeframe

IP: Week 36; CP: Week 12; FU phase: Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	14	0 ^[16]	1	25	6	17	26	8	17
Units: percentage of participants
number (not applicable)
IP Week 36:<LLOQ Td & Nd (n=14,0,1, 0,0,0,0,0,0)	42.9		100.0	99999	99999	99999	99999	99999	99999
IP Week 36:<LLOQ for TNd(n=14,0,1, 0,0,0,0,0,0)	0		0	99999	99999	99999	99999	99999	99999
IP Week 36:<LLOQ for Td(14,0,1, 0,0,0,0,0,0)	42.9		100.0	99999	99999	99999	99999	99999	99999
IP Week 36:<60 IU/mL(14,0,1, 0,0,0,0,0,0)	64.3		100.0	99999	99999	99999	99999	99999	99999
IP Week 36:<100 IU/mL (14,0,1, 0,0,0,0,0,0)	71.4		100.0	99999	99999	99999	99999	99999	99999
IP Week 36:<200 IU/mL (14,0,1, 0,0,0,0,0,0)	78.6		100.0	99999	99999	99999	99999	99999	99999
IP Week 36:<1000 IU/mL(n=14,0,1, 0,0,0,0,0,0)	92.9		100.0	99999	99999	99999	99999	99999	99999
IP Week 36:<2000 IU/mL(n=14,0,1, 0,0,0,0,0,0)	92.9		100.0	99999	99999	99999	99999	99999	99999
IP Week 36:<20000 IU/mL(n=14,0,1, 0,0,0,0,0,0)	92.9		100.0	99999	99999	99999	99999	99999	99999
CP Week 12:<LLOQ:Td & Nd(n=0,0,0,25,6,17,0,0,0)	99999		99999	32.0	33.3	29.4	99999	99999	99999
CP Week 12:<LLOQ for TNd(n=0,0,0,25,6,17,0,0,0)	99999		99999	0	0	0	99999	99999	99999
CP Week 12:<LLOQ for Td(n=0,0,0,25,6,17,0,0,0)	99999		99999	32.0	33.3	29.4	99999	99999	99999
CP Week 12:<60 IU/mL(n=0,0,0,25,6,17,0,0,0)	99999		99999	76.0	50.0	58.8	99999	99999	99999
CP Week 12:<100 IU/mL(n=0,0,0,25,6,17,0,0,0)	99999		99999	92.0	83.3	64.7	99999	99999	99999
CP Week 12:<200 IU/mL(n=0,0,0,25,6,17,0,0,0)	99999		99999	96.0	83.3	82.4	99999	99999	99999
CP Week 12:<1000 IU/mL(n=0,0,0,25,6,17,0,0,0)	99999		99999	100.0	100.0	94.1	99999	99999	99999
CP Week 12:<2000 IU/mL(n=0,0,0,25,6,17,0,0,0)	99999		99999	100.0	100.0	100.0	99999	99999	99999
CP Week 12:<20000 IU/mL(n=0,0,0,25,6,17,0,0,0)	99999		99999	100.0	100.0	100.0	99999	99999	99999
FU Week 48:<LLOQ Td & Nd(n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	84.6	50.0	88.2
FU Week 48: <LLOQ for TNd (n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	34.6	16.7	17.6
FU Week 48:<LLOQ for Td(n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	50.0	33.3	70.6
FU Week 48:<60 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	92.3	50.0	94.1
FU Week 48:<100 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	100.0	66.7	100.0
FU Week 48:<200 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	100.0	83.3	100.0
FU Week 48:<1000 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	100.0	83.3	100.0
FU Week 48:<2000 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	100.0	83.3	100.0
FU Week 48:<20000 IU/mL(n=0,0,0,0,0,0,26,6,17)	99999		99999	99999	99999	99999	100.0	100.0	100.0

Notes
[16] - No participant was available for the analysis.

No statistical analyses for this end point

Secondary: Percentage of Participants with Virologic Breakthrough

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End point title

Percentage of Participants with Virologic Breakthrough

End point description

Percentage of participants with virologic breakthrough on treatment were reported. Virological breakthrough was defined as confirmed on-treatment HBV DNA increase by >1 log10 IU/mL from nadir level (lowest level reached during treatment) in participants who did not have on-treatment HBV DNA level < LLOQ (<20 IU/mL) or confirmed on-treatment HBV DNA level >200 IU/mL in participants who had on-treatment HBV DNA level <LLOQ of the HBV DNA assay. Confirmed HBV DNA increase/level means that the criterion was fulfilled at 2 or more consecutive time points or at the last observed on-treatment time point. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA.

End point type

Secondary

End point timeframe

IP: From Day 1 up to end of IP (up to Week 36 per PA 5; up to Week 52 prior to PA 5); CP: CP Week 1 up to CP Week 12; FU phase: FU Week 1 up to FU Week 48

End point values	IP: Cohort 1(Prior PA 5): JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 1 (Per PA 5): JNJ-3989 + NA + PegIFN-alpha-2a	IP:Cohort 2(Per PA 6): JNJ-3989+NA+PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19	25	7	17	26	8	17
Units: percentage of participants
number (not applicable)	3.7	12.5	0	0	0	0	0	50.0	0

No statistical analyses for this end point

Secondary: Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up

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End point title

Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up

End point description

Percentage of participants who reached HBV DNA undetectability after re-start of NA treatment during follow-up were reported. Undetectability of HBV DNA was defined as HBV DNA<LLOQ that is <20 IU/mL. Treated analysis set included all participants who received at least 1 dose of study treatment within this ISA. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint.

End point type

Secondary

End point timeframe

FU phase: FU Week 1 up to FU Week 48

End point values	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a
Number of subjects analysed	27	8	19
Units: percentage of participants
number (not applicable)	0	0	0

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])

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End point title

Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])

End point description

Cmax of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Noncompartmental analysis were conducted to analyze Cmax JNJ-73763989 and its molecules. Pharmacokinetics analysis set (PK): included participants who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Data for this endpoint was planned to be collected and analysed as pooled cohort in induction phase and consolidation phase only.

End point type

Secondary

End point timeframe

IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8

End point values	Induction phase	Consolidation phase
Number of subjects analysed	8	6
Units: nanogram per milliliters (ng/mL)
arithmetic mean (standard deviation)
JNJ-73763976	1376 ( 1266 )	700 ( 227 )
JNJ-73763924	279 ( 308 )	135 ( 39.9 )

No statistical analyses for this end point

Secondary: Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])

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End point title

Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])

End point description

Time to reach the maximum observed plasma concentration (tmax) of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted to analyze tmax of JNJ-73763989 and its molecules. Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint. Data for this endpoint was planned to be collected and analysed as pooled cohort in induction phase and consolidation phase only.

End point type

Secondary

End point timeframe

IP : Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on IP Week 24; CP: Predose (0 hour), post dose on 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 24 hours on CP Week 8

End point values	Induction phase	Consolidation phase
Number of subjects analysed	8	6
Units: hour
median (full range (min-max))
JNJ-73763976	5.53 (2.50 to 6.00)	3.99 (2.98 to 6.00)
JNJ-73763924	4.00 (0.50 to 5.73)	2.99 (1.00 to 4.00)

No statistical analyses for this end point

Secondary: Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])

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End point title

Plasma Concentration 24 Hours After Administration (C24h) of JNJ-73763989 (Molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])

End point description

Plasma concentration 24 hours after administration (C24h) of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted to analyze C24h of JNJ-73763989 and its molecules. Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint. Data for this endpoint was planned to be collected and analysed as pooled cohort in induction phase and consolidation phase only.

End point type

Secondary

End point timeframe

IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit

End point values	Induction phase	Consolidation phase
Number of subjects analysed	7	6
Units: ng/mL
arithmetic mean (standard deviation)
JNJ-73763976	315 ( 213 )	381 ( 155 )
JNJ-73763924	36.9 ( 27.9 )	54.7 ( 25.0 )

No statistical analyses for this end point

Secondary: Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 hours)] of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])

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End point title

Area Under the Plasma Concentration-time Curve From Time Zero to 24 Hours [AUC (0- 24 hours)] of JNJ-73763989 (molecules: JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924])

End point description

Area under the plasma concentration-time curve from time zero to 24hours (AUC0 to 24h) of JNJ-73763989 (molecules:JNJ-73763976 [JNJ3976], JNJ-73763924 [JNJ-3924]) were reported. Non-compartmental analysis were conducted toanalyze AUC0 to 24h of JNJ-73763989 and its molecules. Pharmacokinetics analysis set (PK): included participants who have received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of participants analysed) signifies the number of participants that were evaluable for this endpoint. Data for this endpoint was planned to be collected and analysed as pooled cohort in induction phase and consolidation phase only.

End point type

Secondary

End point timeframe

IP: 24 hours post dose on Week 24 visit; CP: 24 hours post dose on Week 8 visit

End point values	Induction phase	Consolidation phase
Number of subjects analysed	7	6
Units: nanogramshour per milliliters (ngh/mL)
arithmetic mean (standard deviation)
JNJ-73763976	19109 ( 12482 )	12219 ( 3499 )
JNJ-73763924	3089 ( 1964 )	2117 ( 639 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

IP: From Day 1 up to end of IP (up to Week 36 per PA 5; up to Week 52 prior to PA 5); CP: CP Week 1 up to CP Week 12; FU phase: FU Week 1 up to FU Week 48

Adverse event reporting additional description

Safety analysis was based on safety analysis set which included all participants who received at least one dose of study intervention and were analysed according to the study intervention they actually received.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

IP: Cohort 1-Per PA 5: JNJ-3989 + NA + PegIFN-alpha-2a

Reporting group description

Per PA 5, participants received JNJ-3989 200 mg SC injection for Q4W plus NA (TAD 245 mg/TAF 25 mg) tablets orally QD in IP for 36 weeks.

Reporting group title

IP: Cohort 1-prior PA5: JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a

Reporting group description

Reporting group title

FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a

Reporting group description

Reporting group title

FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a

Reporting group description

Reporting group title

CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a

Reporting group description

Reporting group title

IP: Cohort 2 - Per PA 6: JNJ-3989 + NA + PegIFN-alpha-2a

Reporting group description

Participants enrolled as per PA 6, received JNJ-3989 200 mg SC for Q4W plus NA (TAD 250 mg/TAF 25 mg) tablet orally QD in IP for 36 weeks.

Reporting group title

CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a

Reporting group description

Serious adverse events	IP: Cohort 1-Per PA 5: JNJ-3989 + NA + PegIFN-alpha-2a	IP: Cohort 1-prior PA5: JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 2 - Per PA 6: JNJ-3989 + NA + PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	IP: Cohort 1-Per PA 5: JNJ-3989 + NA + PegIFN-alpha-2a	IP: Cohort 1-prior PA5: JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	CP: Cohort 2 (Per PA 6): JNJ-3989 + NA + PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989+ JNJ-6379+NA+PegIFN-alpha-2a	FU: Cohort 1: JNJ-3989 + NA + PegIFN-alpha-2a	CP:Cohort 1(Prior PA 5):JNJ-3989+JNJ-6379+NA+PegIFN-alpha-2a	IP: Cohort 2 - Per PA 6: JNJ-3989 + NA + PegIFN-alpha-2a	CP: Cohort 1(Per PA 5): JNJ-3989+NA+ PegIFN-alpha-2a
Total subjects affected by non serious adverse events
subjects affected / exposed	8 / 8 (100.00%)	19 / 27 (70.37%)	11 / 17 (64.71%)	13 / 17 (76.47%)	15 / 26 (57.69%)	5 / 8 (62.50%)	21 / 25 (84.00%)	15 / 19 (78.95%)	7 / 7 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of Liver
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
General disorders and administration site conditions
Hyperthermia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	2 / 25 (8.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	2	0	1
Fatigue
subjects affected / exposed	2 / 8 (25.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	4 / 17 (23.53%)	0 / 26 (0.00%)	1 / 8 (12.50%)	5 / 25 (20.00%)	2 / 19 (10.53%)	2 / 7 (28.57%)
occurrences all number	3	1	0	4	0	1	5	2	2
Chills
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	2 / 25 (8.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	0
Asthenia
subjects affected / exposed	0 / 8 (0.00%)	2 / 27 (7.41%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	3	0	1	0	0	2	0	0
Injection Site Erythema
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	3 / 17 (17.65%)	0 / 26 (0.00%)	0 / 8 (0.00%)	3 / 25 (12.00%)	1 / 19 (5.26%)	1 / 7 (14.29%)
occurrences all number	1	0	0	3	0	0	13	1	1
Injection Site Bruising
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	1	1	0	0	0	1	0
Influenza Like Illness
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	2 / 17 (11.76%)	2 / 26 (7.69%)	0 / 8 (0.00%)	4 / 25 (16.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	1	2	2	0	6	0	1
Injection Site Pain
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	2	0	0	0	0	0	1	0	0
Injection Site Pruritus
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0
Injection Site Rash
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	3	0	1
Injection Site Reaction
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	2 / 25 (8.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	5	0	0	2	0	0
Injury Associated with Device
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	1
Pyrexia
subjects affected / exposed	1 / 8 (12.50%)	1 / 27 (3.70%)	1 / 17 (5.88%)	3 / 17 (17.65%)	1 / 26 (3.85%)	1 / 8 (12.50%)	3 / 25 (12.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	1	2	1	4	2	1	3	1	0
Pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	2 / 17 (11.76%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0
Non-Cardiac Chest Pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	1	0	0
Temperature Intolerance
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	1
Immune system disorders
Seasonal Allergy
subjects affected / exposed	2 / 8 (25.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	1 / 26 (3.85%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	3	0	0	0	1	0	0	0	0
Mite Allergy
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Food Allergy
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Reproductive system and breast disorders
Vaginal Haemorrhage
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	2 / 17 (11.76%)	0 / 17 (0.00%)	1 / 26 (3.85%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	1	4	0	1	0	0	1	0
Epistaxis
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Dyspnoea Exertional
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	1	0	0	0	0	1
Dry Throat
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Cough
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	2 / 17 (11.76%)	0 / 17 (0.00%)	2 / 26 (7.69%)	1 / 8 (12.50%)	0 / 25 (0.00%)	2 / 19 (10.53%)	1 / 7 (14.29%)
occurrences all number	1	0	4	0	2	1	0	2	1
Allergic Sinusitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Dyspnoea
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Respiratory Tract Congestion
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Rhinitis Allergic
subjects affected / exposed	1 / 8 (12.50%)	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0
Sinus Congestion
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0
Productive Cough
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	1 / 8 (12.50%)	1 / 25 (4.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	1	1	0	0
Depressed Mood
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Apathy
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Anxiety Disorder
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0
Investigations
Alanine Aminotransferase Increased
subjects affected / exposed	0 / 8 (0.00%)	8 / 27 (29.63%)	1 / 17 (5.88%)	4 / 17 (23.53%)	0 / 26 (0.00%)	0 / 8 (0.00%)	2 / 25 (8.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	13	1	6	0	0	2	3	0
Aspartate Aminotransferase Increased
subjects affected / exposed	0 / 8 (0.00%)	2 / 27 (7.41%)	0 / 17 (0.00%)	2 / 17 (11.76%)	0 / 26 (0.00%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	4	0	2	0	1	0	0	1
Blood Creatine Phosphokinase Increased
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Blood Alkaline Phosphatase Increased
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Blood Glucose Increased
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0
Body Temperature Increased
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	2 / 25 (8.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0
Glucose Urine Present
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	3	0	0	0
Liver Scan Abnormal
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Ultrasound Liver Abnormal
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
White Blood Cell Count Decreased
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	2 / 25 (8.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0
Weight Decreased
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0
Neutrophil Count Decreased
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	2 / 25 (8.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	2	0	0
Injury, poisoning and procedural complications
Head Injury
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Skin Wound
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Skin Laceration
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	1 / 17 (5.88%)	0 / 17 (0.00%)	1 / 26 (3.85%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	1	0	1	0	0	0	0
Ligament Sprain
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Cardiac disorders
Tachycardia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Sinus Tachycardia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	1
Palpitations
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Nervous system disorders
Amnestic Disorder
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Neuropathy Peripheral
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Headache
subjects affected / exposed	3 / 8 (37.50%)	5 / 27 (18.52%)	1 / 17 (5.88%)	1 / 17 (5.88%)	0 / 26 (0.00%)	1 / 8 (12.50%)	5 / 25 (20.00%)	2 / 19 (10.53%)	0 / 7 (0.00%)
occurrences all number	3	10	2	1	0	1	6	2	0
Dizziness Postural
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Blood and lymphatic system disorders
Leukopenia
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	2 / 26 (7.69%)	0 / 8 (0.00%)	4 / 25 (16.00%)	0 / 19 (0.00%)	2 / 7 (28.57%)
occurrences all number	1	0	0	0	3	0	6	0	2
Anaemia
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	1	0	0	0	1	0	0
Neutropenia
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	1 / 26 (3.85%)	0 / 8 (0.00%)	7 / 25 (28.00%)	0 / 19 (0.00%)	2 / 7 (28.57%)
occurrences all number	1	0	0	1	1	0	12	0	3
Thrombocytopenia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	1	0	0	1	0	1
Ear and labyrinth disorders
Ear Pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Eye disorders
Cataract
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0
Conjunctival Hyperaemia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Visual Impairment
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Myopia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	1
Eye Pruritus
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	2	0
Gastrointestinal disorders
Abdominal Discomfort
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0
Aphthous Ulcer
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	2	0	0	0	0	1	0
Abdominal Pain Upper
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	1 / 26 (3.85%)	0 / 8 (0.00%)	0 / 25 (0.00%)	2 / 19 (10.53%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	1	0	0	2	0
Abdominal Pain Lower
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Abdominal Pain
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	2 / 19 (10.53%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	1	2	0
Abdominal Distension
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	1	0	1	0	0	0	2	0
Constipation
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	0
Dental Caries
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	0
Haemorrhoids
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Gastrooesophageal Reflux Disease
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	2 / 19 (10.53%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	2	0
Food Poisoning
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Dyspepsia
subjects affected / exposed	0 / 8 (0.00%)	2 / 27 (7.41%)	0 / 17 (0.00%)	1 / 17 (5.88%)	1 / 26 (3.85%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	2	0	1	1	0	0	0	0
Diarrhoea
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	1 / 26 (3.85%)	0 / 8 (0.00%)	2 / 25 (8.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	2	0	2	1	0
Large Intestine Polyp
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Nausea
subjects affected / exposed	3 / 8 (37.50%)	4 / 27 (14.81%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	2 / 19 (10.53%)	0 / 7 (0.00%)
occurrences all number	3	4	0	0	0	0	0	2	0
Mouth Ulceration
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Rectal Haemorrhage
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Vomiting
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Toothache
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0
Skin and subcutaneous tissue disorders
Eczema
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0
Rash Maculo-Papular
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	0	0	0	0	0	0	0	1
Skin Irritation
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Alopecia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	1 / 26 (3.85%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0
Skin Ulcer
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Renal and urinary disorders
Dysuria
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Musculoskeletal and connective tissue disorders
Pain in Extremity
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	1 / 17 (5.88%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	2 / 7 (28.57%)
occurrences all number	1	0	1	1	0	0	0	1	2
Muscular Weakness
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	1 / 7 (14.29%)
occurrences all number	0	1	0	0	0	0	0	0	1
Muscle Spasms
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0
Limb Mass
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Back Pain
subjects affected / exposed	1 / 8 (12.50%)	2 / 27 (7.41%)	0 / 17 (0.00%)	1 / 17 (5.88%)	1 / 26 (3.85%)	0 / 8 (0.00%)	0 / 25 (0.00%)	2 / 19 (10.53%)	0 / 7 (0.00%)
occurrences all number	1	2	0	1	1	0	0	2	0
Arthralgia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	1	1	0	0	13	1	0
Myalgia
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	2 / 25 (8.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	1	0	0	0	0	3	1	0
Infections and infestations
Aspergilloma
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Acarodermatitis
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Lower Respiratory Tract Infection
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Carbuncle
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Conjunctivitis
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	1 / 7 (14.29%)
occurrences all number	0	1	0	1	0	0	0	1	1
Covid-19
subjects affected / exposed	2 / 8 (25.00%)	2 / 27 (7.41%)	0 / 17 (0.00%)	0 / 17 (0.00%)	7 / 26 (26.92%)	1 / 8 (12.50%)	3 / 25 (12.00%)	4 / 19 (21.05%)	0 / 7 (0.00%)
occurrences all number	2	2	0	0	7	1	3	4	0
Hepatitis B
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Influenza
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	1	0	1	0	0	0	1	0
Lower Respiratory Tract Infection Viral
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Nasopharyngitis
subjects affected / exposed	0 / 8 (0.00%)	2 / 27 (7.41%)	2 / 17 (11.76%)	0 / 17 (0.00%)	4 / 26 (15.38%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	2	2	0	5	0	0	0	0
Oral Herpes
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Paronychia
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Periodontitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Respiratory Tract Infection
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	1 / 17 (5.88%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	1	0	0	0	0	0
Urinary Tract Infection
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	2 / 8 (25.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	2	0	1	0
Viral Infection
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Respiratory Tract Infection Viral
subjects affected / exposed	1 / 8 (12.50%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Upper Respiratory Tract Infection
subjects affected / exposed	0 / 8 (0.00%)	1 / 27 (3.70%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	2 / 19 (10.53%)	0 / 7 (0.00%)
occurrences all number	0	1	3	0	0	0	0	3	0
Sinusitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	1 / 17 (5.88%)	1 / 26 (3.85%)	0 / 8 (0.00%)	0 / 25 (0.00%)	1 / 19 (5.26%)	1 / 7 (14.29%)
occurrences all number	0	0	1	1	1	0	0	1	1
Metabolism and nutrition disorders
Decreased Appetite
subjects affected / exposed	0 / 8 (0.00%)	2 / 27 (7.41%)	0 / 17 (0.00%)	2 / 17 (11.76%)	0 / 26 (0.00%)	0 / 8 (0.00%)	1 / 25 (4.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	2	0	2	0	0	1	0	0
Iron Deficiency
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	0 / 17 (0.00%)	0 / 17 (0.00%)	0 / 26 (0.00%)	1 / 8 (12.50%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Vitamin B12 Deficiency
subjects affected / exposed	0 / 8 (0.00%)	0 / 27 (0.00%)	1 / 17 (5.88%)	0 / 17 (0.00%)	0 / 26 (0.00%)	0 / 8 (0.00%)	0 / 25 (0.00%)	0 / 19 (0.00%)	0 / 7 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

30 Jul 2021

Amendment 5: The purpose for this amendment was a change in study treatment regimens, based on the availability of preliminary 48-week treatment data from the Phase 2b study REEF-1 (73763989HPB2001), and new data presented during the European Association for the Study of the Liver (EASL) conference of 2021 showing that HBsAg declines with siRNA treatment can be increased when combined with PegIFN.

30 Sep 2021

Amendment 6: The purpose for this amendment was to remove JNJ-6379 as study intervention, to add a new nucleos(t)ide analog (NA) re-treatment criterion for subjects who discontinued NA treatment during follow-up, and to include more frequent monitoring for subjects who discontinued NA treatment during follow-up.

25 Nov 2021

Amendment 7: The purpose of amendment was to update the criteria for post-treatment monitoring and for nucleos(t)ide analog (NA) re-treatment for participants who discontinued NA treatment during follow-up.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping all Study Interventions at the end of Consolidation Phase (CP) and Without Restarting Nucleos(t)ide analog (NA) Treatment

Primary: Percentage of Participants With Functional Cure: Hepatitis B Surface Antigen (HBsAg) Seroclearance at 24 Weeks After Stopping all Study Interventions at the end of Consolidation Phase (CP) and Without Restarting Nucleos(t)ide analog (NA) Treatment

Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Secondary: Number of Participants with Treatment Emergent Adverse Events (TEAEs)

Secondary: Number of Participants with Treatment Emergent Serious Adverse Events (TESAEs)

Secondary: Number of Participants with Treatment Emergent Serious Adverse Events (TESAEs)

Secondary: Number of Participants with Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests

Secondary: Number of Participants with Worst (Grade 3 or 4) Treatment-emergent DAIDS Toxicity Grade in Clinical Laboratory Tests

Secondary: Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs)

Secondary: Number of Participants With Worst Treatment-emergent Abnormality in Electrocardiogram (ECGs)

Secondary: Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs

Secondary: Number of Participants With Worst Treatment-emergent Abnormalities in Vital Signs

Secondary: Number of Participants With Clinically Important Abnormalities in Physical Examination

Secondary: Number of Participants With Clinically Important Abnormalities in Physical Examination

Secondary: Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)

Secondary: Percentage of Participants Who Reached HBsAg Less Than (<) 10 (International Units Per Milliliter [IU/mL]) at the End of the Induction Phase (EOI)

Secondary: Time to Achieve First Occurrence of HBsAg <10 IU/mL

Secondary: Time to Achieve First Occurrence of HBsAg <10 IU/mL

Secondary: FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase

Secondary: FU Phase: Percentage of Participants With HBsAg Seroclearance 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase

Secondary: FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase

Secondary: FU Phase: Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <LLOQ 48 Weeks After Stopping All Study Interventions of the Consolidation Phase and Without Restarting NA Treatment During Follow up Phase

Secondary: Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase

Secondary: Percentage of Participants Who Met Nucleos(t)Ide Analog (NA) Treatment Completion Criteria at the End of Consolidation Phase

Secondary: FU Phase: Number of Participants with Off-treatment Virologic HBV Flares During Follow up Phase

Secondary: FU Phase: Number of Participants with Off-treatment Virologic HBV Flares During Follow up Phase

Secondary: FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase

Secondary: FU Phase: Number of Participants With On-treatment Biochemical Flares During Follow-up Phase

Secondary: FU Phase: Number of Participants with Off-treatment Biochemical HBV Flares During Follow-up Phase

Secondary: FU Phase: Number of Participants with Off-treatment Biochemical HBV Flares During Follow-up Phase

Secondary: FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase

Secondary: FU Phase: Number of Participants With Off-treatment Clinical Flares During Follow-up Phase

Secondary: FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase

Secondary: FU Phase: Percentage of Participants Who Required NA Re-treatment During Follow-Up Phase

Secondary: FU phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48

Secondary: FU phase: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 1) at Follow-up Week 48

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 3) at Follow-up Week 48

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 2) at Follow-up Week 48

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48

Secondary: Percentage of Participants Who Achieved Reduction (Sustained) in HBsAg Response (Per Definition 4) at Follow-up Week 48

Secondary: Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48

Secondary: Percentage of Participants With HBsAg Seroclearance at Follow-up Week 48

Secondary: Percentage of Participants with HBeAg Seroclearance at Follow-up Week 48

Secondary: Percentage of Participants with HBeAg Seroclearance at Follow-up Week 48

Secondary: Percentage of Participants with HBsAg Seroconversion

Secondary: Percentage of Participants with HBsAg Seroconversion

Secondary: Percentage of Participants with HBeAg Seroconversion

Secondary: Percentage of Participants with HBeAg Seroconversion

Secondary: Change from baseline over time in HBsAg Levels

Secondary: Change from baseline over time in HBsAg Levels

Secondary: Change from baseline over time in HBeAg Levels

Secondary: Change from baseline over time in HBeAg Levels

Secondary: Change from Baseline Over Time in HBV DNA Levels

Secondary: Change from Baseline Over Time in HBV DNA Levels

Secondary: Time to Achieve First HBsAg Seroclearance

Secondary: Time to Achieve First HBsAg Seroclearance

Secondary: Time to Achieve First HBV DNA <LLOQ

Secondary: Time to Achieve First HBV DNA <LLOQ

Secondary: Time to Achieve First HBeAg Seroclearance

Secondary: Time to Achieve First HBeAg Seroclearance

Secondary: Percentage of participants with HBeAg Levels Below Different Cut-offs

Secondary: Percentage of participants with HBeAg Levels Below Different Cut-offs

Secondary: Percentage of Participants With HBsAg Levels Below Different Cut-offs

Secondary: Percentage of Participants With HBsAg Levels Below Different Cut-offs

Secondary: Percentage of Participants With HBV DNA Levels Below Different Cut-offs

Secondary: Percentage of Participants With HBV DNA Levels Below Different Cut-offs

Secondary: Percentage of Participants with Virologic Breakthrough

Secondary: Percentage of Participants with Virologic Breakthrough

Secondary: Percentage of Participants Who Reached HBV DNA Undetectability After Re-start of NA Treatment During Follow-up