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    Clinical Trial Results:
    A Phase 2, Open-label, Single-arm, Multicenter Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of Treatment With JNJ-73763989, JNJ-56136379, Nucleos(t)ide Analogs, and Pegylated Interferon Alpha-2a in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection

    Summary
    EudraCT number
    		 2020-003956-34
    Trial protocol
    		 PL  
    Global end of trial date
    17 Apr 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 May 2024
    First version publication date
    02 May 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    73763989PAHPB2006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04667104
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Highway 202, Raritan, NJ, United States, 08869-1420
    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
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Apr 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Apr 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to assess efficacy and safety of a treatment regimen of JNJ-73763989 (JNJ-3989), JNJ-56136379 (JNJ-6379), and Nucleos(t)ide Analogs (NA) for 24 weeks with addition of Pegylated Interferon Alpha-2aNA (PegIFN-alpha2a) for 24 weeks.
    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
    01 Feb 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Japan: 5
    Country: Number of subjects enrolled
    New Zealand: 4
    Country: Number of subjects enrolled
    Poland: 14
    Country: Number of subjects enrolled
    Taiwan: 25
    Worldwide total number of subjects
    48
    EEA total number of subjects
    14
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 At Week 12, subjects were assessed for PegIFN-alpha2a (PegIFN-alpha 2a) eligibility criteria & those who did not meet the criteria continued in Treatment Period 1 (TP 1) until Week 24 and those who met the criteria entered Treatment Period 2 (TP 2). After Week 12, one subject continued with TP1 regimen during TP2 until Week 24.

    Period 1
    Period 1 title
    TP 1: From Week 1 to Week 12
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
    Arm description
    		 Subjects received JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir [ETV] 0.5 mg, tenofovir disoproxil fumarate [TDF] 245 mg, or tenofovir alafenamide [TAF] 25 mg) QD up to 12 weeks in TP 1. Subjects enrolled until Protocol Amendment 3, also received single dose of JNJ-6379 250 mg orally as part of their study intervention. Subjects enrolled after Protocol Amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Subjects were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12 and those who met the criteria entered TP 2.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    JNJ-3989
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received a single dose of JNJ-73763989 200 mg administered as SC injection in abdomen Q4W up to 12 weeks.

    Investigational medicinal product name
    JNJ-56136379
    Investigational medicinal product code
    Other name
    JNJ-6379
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of JNJ-56136379 250 mg tablets administered orally up to 12 weeks.

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-Entecavir (ETV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of ETV 0.5 mg film-coated tablets administered orally up to 12 weeks.

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-Tenofovir alafenamide (TAF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of TAF 25 mg film-coated tablets administered orally up to 12 weeks.

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-Tenofovir disoproxil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single dose of tenofovir disoproxil 245 mg film-coated tablets administered orally up to 12 weeks.

    Number of subjects in period 1
    		TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
    Started
    48
    Completed
    48
    Period 2
    Period 2 title
    TP 2: From Week 12 to Week 24
    Is this the baseline period?
    		 No
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Arm description
    		 Subjects who met the eligibility criteria for PegIFN-alpha2a (subjects who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg), QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (Q1W) during TP 2. Subjects enrolled until Protocol Amendment 3, also received single dose of JNJ-6379 250 mg orally as part of their study intervention. Subjects enrolled after Protocol Amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    JNJ-3989
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    From Week 12, subjects received a single dose of JNJ-73763989 200 mg administered as SC injection in abdomen Q4W up to 12 weeks.

    Investigational medicinal product name
    PegIFN-alpha2a
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    From Week 12, subjects received a single dose of PegIFN-alpha2a 180 mcg QW administered as SC injection in the thigh or abdomen for 12 weeks.

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-ETV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    From Week 12, subjects received a single dose of 0.5 mg ETV film-coated tablets administered orally up to 12 weeks.

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-Tenofovir disoproxil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    From Week 12, subjects received a single dose of 245 mg tenofovir disoproxil film-coated tablets administered orally up to 12 weeks.

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    From Week 12, subjects received a single dose of 25 mg TAF film-coated tablets administered orally up to 12 weeks.

    Investigational medicinal product name
    JNJ-56136379
    Investigational medicinal product code
    Other name
    JNJ-6379
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    From Week 12, subjects received a single dose of JNJ-56136379 250 mg tablets administered orally up to 12 weeks.

    Number of subjects in period 2
    		TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Started
    48
    Completed
    48
    Period 3
    Period 3 title
    Follow-Up Period: From Week 24 - Week 72
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Arm description
    		 At Week 24, prior to follow-up period, all subjects stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Subjects who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen [HBsAg] <10 international units/millilitre [IU/mL], and hepatitis B e antigen [HBeAg]-negative, and hepatitis B virus deoxyribonucleic acid [HBV DNA] <lower limit of quantification [LLOQ], and alanine aminotransferase [ALT] <3*Upper limit of normal [ULN]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Subjects who did not meet NA completion criteria continued NA treatment during the follow-up period up to Week 72 (that is, follow-up Week 48).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-Tenofovir disoproxil
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At Week 24, subjects received a single dose of tenofovir disoproxil 245 mg film-coated tablets administered orally up to 48 weeks.

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-ETV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At Week 24, subjects received a single dose of ETV 0.5 mg film-coated tablets administered orally up to 48 weeks.

    Investigational medicinal product name
    Nucleos(t)ide analog (NA)-TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At Week 24, subjects received a single dose of TAF 25 mg film-coated tablets administered orally up to 48 weeks.

    Number of subjects in period 3
    		Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Started
    48
    Completed
    47
    Not completed
    1
         Unspecified
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
    Reporting group description
    		 Subjects received JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir [ETV] 0.5 mg, tenofovir disoproxil fumarate [TDF] 245 mg, or tenofovir alafenamide [TAF] 25 mg) QD up to 12 weeks in TP 1. Subjects enrolled until Protocol Amendment 3, also received single dose of JNJ-6379 250 mg orally as part of their study intervention. Subjects enrolled after Protocol Amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Subjects were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12 and those who met the criteria entered TP 2.

    Reporting group values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA Total
    Number of subjects
    		 48 48
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 48 48
        From 65 to 84 years
    		 0 0
        85 years and over
    		 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.6 ( 1.47 ) -
    Title for Gender
    Units: subjects
        Female
    		 8 8
        Male
    		 40 40

    End points

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    End points reporting groups
    Reporting group title
    TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
    Reporting group description
    		 Subjects received JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir [ETV] 0.5 mg, tenofovir disoproxil fumarate [TDF] 245 mg, or tenofovir alafenamide [TAF] 25 mg) QD up to 12 weeks in TP 1. Subjects enrolled until Protocol Amendment 3, also received single dose of JNJ-6379 250 mg orally as part of their study intervention. Subjects enrolled after Protocol Amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Subjects were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12 and those who met the criteria entered TP 2.
    Reporting group title
    TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Reporting group description
    		 Subjects who met the eligibility criteria for PegIFN-alpha2a (subjects who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg), QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (Q1W) during TP 2. Subjects enrolled until Protocol Amendment 3, also received single dose of JNJ-6379 250 mg orally as part of their study intervention. Subjects enrolled after Protocol Amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only.
    Reporting group title
    Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Reporting group description
    		 At Week 24, prior to follow-up period, all subjects stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Subjects who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen [HBsAg] <10 international units/millilitre [IU/mL], and hepatitis B e antigen [HBeAg]-negative, and hepatitis B virus deoxyribonucleic acid [HBV DNA] <lower limit of quantification [LLOQ], and alanine aminotransferase [ALT] <3*Upper limit of normal [ULN]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Subjects who did not meet NA completion criteria continued NA treatment during the follow-up period up to Week 72 (that is, follow-up Week 48).

    Subject analysis set title
    Pooled(JNJ-3989 200mg+JNJ-6379 250mg+PegIFN-alpha2a 180mcg+NA)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects received JNJ-3989 200 mg as SC Q4W along with JNJ-6379 250 mg tablet QD and NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg QD up to 12 weeks in TP1. At Week 12, subjects who met eligibility criteria for PegIFN-alpha 2a entered TP2. Subjects in TP2 received combination treatment of JNJ-3989 200 mg SC injection Q4W with NA treatment up to Week 24 plus PegIFN-alpha 2a 180 mcg Q1W. At Week 24, before follow-up period, subjects stopped JNJ-3989 + JNJ-6379 + PegIFN-alpha2a. At Week 26, those who met the NA treatment completion criteria stopped NA (follow up Week 2) and those who did not meet criteria continued NA treatment in follow-up period up to Week 72 (follow-up Week 48). Subjects enrolled until Protocol Amendment 3 (PA3), also received JNJ-6379 250 mg orally as intervention in TP1 and TP2 and those enrolled after PA3, received only JNJ-3989 + PegIFN alpha 2a + NA only during study.

    Primary: Percentage of Subjects with a Reduction of at Least 2 log10 International Unit/millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline (Day 1) to Week 24

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    End point title
    		 Percentage of Subjects with a Reduction of at Least 2 log10 International Unit/millilitres (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels From Baseline (Day 1) to Week 24 [1]
    End point description
    Percentage of subjects with a reduction of at least 2 log10IU/mL in HBsAg levels from baseline to Week 24 were reported. A responder was defined as a subject with reduction of at least 2 log10 IU/mL in HBsAg levels from Baseline at Week 24. Full Analysis Set (FAS) included all subjects who were enrolled and who received at least 1 dose of study intervention within this intervention-specific appendix (ISA). Data for this endpoint was planned to be collected and analyzed for specified arm only.
    End point type
    Primary
    End point timeframe
    Baseline (Day 1) to 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 formal statistical testing was planned. Only descriptive analysis was performed.
    End point values
    		 TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Number of subjects analysed
    48
    Units: percentage of subjects
        number (confidence interval 90%)
    64.6 (51.73 to 76.02)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability

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    End point title
    		 Percentage of Subjects with Treatment Emergent Adverse Events (TEAEs) as a Measure of Safety and Tolerability
    End point description
    Percentage of subjects with TEAEs were reported. An adverse event (AE) was any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. Safety analysis set included all subjects who received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: percentage of subjects
        number (not applicable)
    52.1
    87.5
    60.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability

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    End point title
    		 Percentage of Subjects with Treatment Emergent Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
    End point description
    An AE is any untoward medical occurrence in a subject participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were AEs with onset during the intervention period or follow-up period or that were a consequence of a pre-existing condition that had worsened since baseline. 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. Safety analysis set included all subjects who received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: percentage of subjects
        number (not applicable)
    0
    2.1
    8.3
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability

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    End point title
    		 Number of Subjects with Clinically Significant Abnormalities in Vital Signs as a Measure of Safety and Tolerability
    End point description
    Number of subjects with clinically significant abnormalities in vital signs (pulse rate, and blood pressure [systolic and diastolic]) were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability

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    End point title
    		 Number of Subjects with Clinically Significant Abnormalities in Laboratory Findings as a Measure of Safety and Tolerability
    End point description
    Number of subjects with clinically significant abnormalities in laboratory findings (including hematology, blood biochemistry, and urinalysis) were reported. Only parameters in which any subject had abnormality are reported below. Safety analysis set included all subjects who received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they actually received. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: subjects
        Treatment-emergent (TE)-Grade 3 ALT elevations
    1
    1
    1
        TE-Grade 3 total bilirubin elevations
    0
    0
    1
        TE-Grade 3 direct bilirubin elevations
    0
    0
    2
        Treatment-emergent-High serum indirect bilirubin
    0
    0
    3
        Renal complications-eGFR Decreases
    0
    0
    0
        Hematology-low absolute neutrophil count Grade 1
    1
    13
    2
        Hematology-low absolute neutrophil count Grade 2
    0
    2
    1
        Hematology-low absolute neutrophil count Grade 3
    0
    3
    0
        Hematology-low absolute neutrophil count Grade 4
    0
    1
    0
        Hematology-low absolute lymphocyte count Grade 1
    1
    1
    0
        Hematology-low absolute lymphocyte count Grade 2
    1
    3
    0
        Hematology-low absolute lymphocyte count Grade 3
    0
    3
    2
        Hematology-low absolute lymphocyte count Grade 4
    0
    1
    1
        Hematology-decreased platelets of Grade 1
    0
    20
    8
        Hematology-decreased platelets of Grade 2
    0
    5
    0
        Hematology-low hemoglobin Grade 2
    0
    0
    1
        Hematology-low WBC count of Grade 1
    0
    14
    5
        Hematology-low WBC count of Grade 2
    0
    6
    1
        Hematology-low WBC count of Grade 3
    0
    2
    0
        Chemistry-LDL cholesterol Grade 3
    2
    1
    2
        Chemistry-eGFR creatinine low Grade 3 elevation
    1
    0
    0
        Chemistry-eGFR Cystatin C low Grade 3 elevation
    0
    1
    2
        Chemistry-Grade 3 elevations in triglycerides
    0
    2
    0
        Chemistry-Grade 3 elevation amylase
    0
    0
    1
        Chemistry-Grade 3 elevation direct bilirubin high
    0
    0
    2
        Chemistry-lipaseGrade 4 elevation
    0
    0
    1
        Urinalysis-Grade 1 glycosuria (n=0, 0, 24)
    0
    0
    1
        Urinalysis-Grade 1 hematuria (n=0, 17, 18)
    0
    1
    1
        Urinalysis-Grade 2 hematuria (n=10, 17, 18)
    1
    1
    1
        Urinalysis-Grade 1 proteinuria (n=19, 23, 24)
    2
    5
    4
        Urinalysis-Grade 2 proteinuria (n=19, 23, 24)
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability

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    End point title
    		 Number of Subjects with Clinically Significant Abnormalities in Physical Examination as a Measure of Safety and Tolerability
    End point description
    Number of subjects with clinically significant abnormalities in physical examination were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they actually received. Data for this outcome measure was not planned to be collected and analyzed for Follow-Up Period as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Number of subjects analysed
    48
    48
    Units: subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability

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    End point title
    		 Number of Subjects with Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECGs) as a Measure of Safety and Tolerability
    End point description
    Number of subjects with clinically significant abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected [QTc]) were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 28
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: subjects
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability

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    End point title
    		 Number of Subjects with Clinically Significant Abnormalities in Ophthalmic Examination as a Measure of Safety and Tolerability
    End point description
    Number of subjects with clinically significant abnormalities in ophthalmic examination were planned to be reported. Safety analysis set included all subjects who received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they actually received. Data for this endpoint was planned to be collected and analyzed in TP 1 and TP 2 for participants with diabetes/hypertension only. Since no subject had diabetes/hypertension, data for this endpoint was not collected and analyzed.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: subjects
    Notes
    [2] - Data was planned to be collected for subjects at risk factor of diabetes or hypertension only.
    [3] - Data was planned to be collected for subjects at risk factor of diabetes or hypertension only.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Levels Below Different Cut-offs

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    End point title
    		 Percentage of Subjects with HBsAg Levels Below Different Cut-offs
    End point description
    Percentage of subjects with HBsAg levels below different cut-offs were reported. The cut-offs for HBsAg levels were as followed: <1000 IU/mL, <100 IU/mL, <10 IU/mL, <1 IU/mL, <LLOQ (0.05 IU/mL). FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: percentage of subjects
    number (not applicable)
        <LLOQ (0.05 IU/mL)
    0
    2.1
    2.1
        <1 IU/mL
    4.2
    6.3
    2.1
        <10 IU/mL
    12.5
    47.9
    4.2
        <100 IU/mL
    58.3
    91.7
    27.1
        <1000 IU/mL
    89.6
    97.9
    68.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Meeting the Protocol-defined Nucleos(t)ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI)

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    End point title
    		 Percentage of Subjects Meeting the Protocol-defined Nucleos(t)ide Analog (NA) Treatment Completion Criteria at End of Study Intervention (EOSI)
    End point description
    Percentage of subjects meeting the protocol-defined NA treatment completion criteria at EOSI were reported. NA treatment completion criteria defined based on laboratory results at Week 24 were; HBsAg <10 IU/mL; HBeAg-negative; HBV DNA <20 IU/mL, that is, lower limit of quantification (LLOQ); alanine aminotransferase (ALT) <3* Upper Limit of Normal (ULN). FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this endpoint was not planned to be collected and analyzed for Treatment Period 1 and Follow-Up period as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    At Week 24 (EOSI)
    End point values
    		 TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Number of subjects analysed
    48
    Units: percentage of subjects
        number (not applicable)
    31.3
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Subjects with HBeAg Levels Below Different Cut-offs
    End point description
    Percentage of subjects with HBeAg levels below different cut-offs were reported. The cut-offs for HBeAg levels were as followes:< 100 IU/mL, < 10 IU/mL, < 1 IU/mL, < LLOQ (0.11 IU/mL). FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    11
    11
    11
    Units: percentage of subjects
    number (not applicable)
        < LLOQ (0.11 IU/mL)
    36.4
    27.3
    27.3
        < 1 IU/mL
    90.9
    100.0
    81.8
        < 10 IU/mL
    100.0
    100.0
    100.0
        < 100 IU/mL
    100.0
    100.0
    100.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below different Cut-offs

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    End point title
    		 Percentage of Subjects with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Levels Below different Cut-offs
    End point description
    Percentage of subjects with HBV DNA levels below cut-offs were reported. The cut-offs for HBV DNA were as followed: <LLOQ(=20 IU/mL) for target detected and not detected, < LLOQ for target not detected, < LLOQ for target detected, <60 IU/mL, <100 IU/mL, <200 IU/mL, <1000 IU/mL, <2000 IU/mL, <20000 IU/mL. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: percentage of subjects
    number (not applicable)
        < LLOQ for target detected and not detected
    95.8
    75.0
    81.3
        < LLOQ for target not detected
    52.1
    27.1
    54.2
        < LLOQ for target detected
    43.8
    47.9
    27.1
        < 60 IU/mL
    100.0
    89.6
    83.3
        < 100 IU/mL
    100.0
    95.8
    83.3
        < 200 IU/mL
    100.0
    97.9
    85.4
        < 1000 IU/mL
    100.0
    100.0
    89.6
        < 2000 IU/mL
    100.0
    100.0
    93.8
        < 20000 IU/mL
    100.0
    100.0
    97.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroconversion

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    End point title
    		 Percentage of Subjects with HBsAg Seroconversion
    End point description
    Percentage of subjects with HBsAg seroconversion were reported. Seroconversion of HBsAg is defined as having achieved HBsAg seroclearance (defined as HBsAg <LLOQ [0.05 IU/mL]) and appearance of anti-HBs antibodies. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    45
    46
    46
    Units: percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with ALT Levels Greater Than or Equal to (>=) 3*ULN

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    End point title
    		 Percentage of Subjects with ALT Levels Greater Than or Equal to (>=) 3*ULN
    End point description
    Percentage of subjects with ALT levels >=3*ULN were reported. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    3
    3
    3
    Units: percentage of subjects
        number (not applicable)
    33.3
    33.3
    66.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBeAg Seroconversion

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    End point title
    		 Percentage of Subjects with HBeAg Seroconversion
    End point description
    Percentage of subjects with HBeAg seroconversion were reported. Seroconversion of HBeAg was defined as having achieved HBeAg seroclearance (as HBeAg level <LLOQ [0.11 IU/mL]) and appearance of anti-HBe antibodies, defined as baseline anti-HBe antibodies with a negative result and a post-baseline assessment with positive result. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    11
    11
    11
    Units: percentage of subjects
        number (not applicable)
    0
    10.0
    20.0
    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 were reported. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: log10 IU/mL
        arithmetic mean (standard error)
    -1.43 ( 0.070 )
    -2.18 ( 0.084 )
    -0.71 ( 0.092 )
    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. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    48
    Units: log10 IU/mL
        arithmetic mean (standard error)
    0.03 ( 0.032 )
    0.28 ( 0.059 )
    0.36 ( 0.145 )
    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. The baseline assessment was defined as the last observed non-missing measurement before the date and time of the first administration of any of study agent. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of subjects analyzed) signifies the number of subjects that were evaluable for this endpoint and "n"(number analyzed) signifies number of subjects analysed at specified categories.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Baseline (Day 1) up to Week 24; Follow-Up: From Baseline (Day 1) up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    11
    11
    11
    Units: log10 IU/mL
        arithmetic mean (standard error)
    -0.68 ( 0.087 )
    -0.72 ( 0.106 )
    -0.53 ( 0.112 )
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of HBsAg Seroclearance

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    End point title
    		 Time to First Occurrence of HBsAg Seroclearance
    End point description
    Time to first occurrence of HBsAg seroclearance were reported in median time. Time to first occurrence of the 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 the HBsAg seroclearance. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. "9999" signifies that median and range was not estimable as at least 50% subjects did not reach HBsAg seroclearance. Data for this endpoint was planned to be collected and analysed in a single arm.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) up to Week 72
    End point values
    		 Pooled(JNJ-3989 200mg+JNJ-6379 250mg+PegIFN-alpha2a 180mcg+NA)
    Number of subjects analysed
    48
    Units: weeks
        median (full range (min-max))
    99999 (-99999 to 99999)
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of HBeAg Seroclearance

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    End point title
    		 Time to First Occurrence of HBeAg Seroclearance
    End point description
    Time to first occurrence of HBeAg seroclearance were reported in median time. Time to first occurrence of the HBeAg seroclearance is 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. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this endpoint was planned to be collected and analysed in a single arm.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) up to Week 72
    End point values
    		 Pooled(JNJ-3989 200mg+JNJ-6379 250mg+PegIFN-alpha2a 180mcg+NA)
    Number of subjects analysed
    48
    Units: weeks
        median (full range (min-max))
    14.1 (4.1 to 72.4)
    No statistical analyses for this end point

    Secondary: Time to First Occurrence of HBV DNA < LLOQ

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    End point title
    		 Time to First Occurrence of HBV DNA < LLOQ
    End point description
    Time to first occurrence of HBV DNA < LLOQ (20 IU/mL) were reported in median time. Time to first occurrence of the HBV DNA < LLOQ is 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. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this endpoint was planned to be collected and analysed in a single arm.
    End point type
    Secondary
    End point timeframe
    From Baseline (Day 1) up to Week 72
    End point values
    		 Pooled(JNJ-3989 200mg+JNJ-6379 250mg+PegIFN-alpha2a 180mcg+NA)
    Number of subjects analysed
    48
    Units: weeks
        median (full range (min-max))
    4.1 (2.9 to 32.3)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Virologic Breakthrough

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    End point title
    		 Percentage of Subjects with Virologic Breakthrough
    End point description
    Percentage of subjects with virologic breakthrough were reported. It was defined as confirmed on-treatment (the time period during which the subject receives any of the study treatments) HBV DNA increase by >1 log10 IU/mL from nadir or confirmed on-treatment HBV DNA level >200 IU/mL in subjects who had HBV DNA level <LLOQ (20 IU/mL) of the HBV DNA assay. Confirmed means that the criteria was fulfilled at 2 or more consecutive time points or at the last observed time point. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified categories.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    38
    Units: percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroclearance at Week 48 without re-starting NA treatment

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    End point title
    		 Percentage of Subjects with HBsAg Seroclearance at Week 48 without re-starting NA treatment
    End point description
    Proportion of subjects with HBsAg seroclearance at Week 48 (that is, 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported. HBsAg seroclearance was defined as [quantitative] HBsAg <LLOQ (0.05 IU/mL). FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this outcome measure was planned to be collected and analyzed for Follow-Up Period as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    At Week 48 (24 weeks after completion of all study interventions at Week 24)
    End point values
    		 Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    Units: percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment

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    End point title
    		 Percentage of Subjects with HBV DNA < LLOQ at Week 48 Without Re-starting NA Treatment
    End point description
    Percentage of subjects with HBV DNA <LLOQ (20 IU/mL) at Week 48 (that is, 24 weeks after completion of all study interventions at Week 24) without re-starting NA treatment were reported. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Data for this outcome measure was planned to be collected and analyzed for Follow-Up Period only as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    At Week 48 (24 weeks after completion of all study interventions at Week 24)
    End point values
    		 Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    Units: percentage of subjects
        number (not applicable)
    81.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Biochemical Flares

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    End point title
    		 Percentage of Subjects with Biochemical Flares
    End point description
    Percentage of subjects with biochemical flares were reported. On-treatment biochemical flare was defined as confirmed ALT and/or AST >=3*ULN and >=3*nadir, while the subject received any of the study interventions. Off-treatment biochemical flare was defined as confirmed ALT and/or AST =3*ULN and =3*nadir, while the subject did not receive any of the study interventions (Off treatment, including NA). FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified categories. Here "99999" signifies no participant were available for the analysis.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    48
    48
    38
    Units: percentage of subjects
    number (confidence interval 90%)
        On-Treatment (n=48, 48, 38)
    0 (0 to 6.05)
    4.2 (0.75 to 12.54)
    0 (0 to 7.58)
        Off-Treatment (n=0, 0, 15)
    99999 (-99999 to 99999)
    99999 (-99999 to 99999)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
    End point description
    The maximum observed plasma concentrations (Cmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported. Pharmacokinetics(PK) analysis set included all subjects who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified categories. Data for this endpoint was planned to be collected and analyzed for TP 1 and TP 2 only as specified in protocol.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: Day 1 Week 1; Treatment Period 2: Day 1, Week 12
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Number of subjects analysed
    5
    5
    Units: nanograms/milliliters (ng/mL)
    arithmetic mean (standard deviation)
        JNJ-73763976
    1338 ( 971 )
    928 ( 692 )
        JNJ-73763924
    271 ( 197 )
    185 ( 130 )
    No statistical analyses for this end point

    Secondary: Number of Subjects Requiring NA Re-treatment

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    End point title
    		 Number of Subjects Requiring NA Re-treatment
    End point description
    Number of subjects requiring NA re-treatment based on failure in NA treatment completion criteria (HBsAg <10 IU/mL, and HBeAg-negative, and HBV DNA < LLOQ (20 IU/m)L, and ALT <3*ULN) were reported. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified timepoints. Data for this outcome measure was planned to be collected and analyzed for Follow-up Period only as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    Follow-up Period: From Week 24 up to Week 72
    End point values
    		 Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    15
    Units: subjects
    4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Virologic Flares

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    End point title
    		 Percentage of Subjects with Virologic Flares
    End point description
    Percentage of subjects with virologic 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 subjects who were off-treatment. Off-treatment was defined as the time period after stopping all study treatments (including NA) and had HBV DNA <LLOQ (20 IU/mL) at the last observed time point on all study interventions. FAS included all subjects who were enrolled and who received at least 1 dose of study intervention within this ISA. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint and "n"(number of subjects analyzed) signifies number of subjects analyzed at specified categories. Data for this outcome measure was planned to be collected and analyzed for Follow-Up period only as pre-specified in protocol.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    End point values
    		 Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Number of subjects analysed
    15
    Units: percentage of subjects
        number (confidence interval 90%)
    33.3 (14.17 to 57.74)
    No statistical analyses for this end point

    Secondary: Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
    End point description
    Time to reach maximum observed plasma concentration (Cmax) (Tmax) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported. Pharmacokinetics(PK) analysis set included all subjects who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint. Data for this endpoint was planned to be collected and analyzed for TP1 and TP2 only as specified in protocol.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Number of subjects analysed
    5
    5
    Units: hours
    median (full range (min-max))
        JNJ-73763976
    5.50 (2.00 to 6.20)
    6.00 (2.00 to 23.58)
        JNJ-73763924
    2.00 (1.00 to 6.00)
    4.02 (0.50 to 7.72)
    No statistical analyses for this end point

    Secondary: Plasma Concentration 24 Hours after Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)

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    End point title
    		 Plasma Concentration 24 Hours after Administration (C24h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
    End point description
    Plasma concentration 24 hours (C24h) after administration of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported. Pharmacokinetics(PK) Analysis Set included all subjects who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint. Data for this endpoint was planned to be collected and analyzed for TP1 and TP2 only as specified in protocol.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: Day 1 Week 1: Treatment Period 2: Day 1, Week 12
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Number of subjects analysed
    5
    5
    Units: ng/mL
    arithmetic mean (standard deviation)
        JNJ-73763976
    309 ( 145 )
    390 ( 162 )
        JNJ-73763924
    38.7 ( 16.2 )
    57.4 ( 15.9 )
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)

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    End point title
    		 Area Under the Plasma Concentration Versus Time Curve From Time 0 to 24 hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924)
    End point description
    Area under the plasma concentration versus time curve from time 0 to 24 hour (AUC[0-24]h) of JNJ-73763989 (JNJ-73763976 and JNJ-73763924) were reported. Pharmacokinetics(PK) analysis set included all subjects who received at least 1 dose of study intervention and had at least 1 valid blood sample drawn for PK analysis. Here "N" (Number of subjects that started the Arm) signifies the number of subjects that were evaluable for this endpoint. Data for this endpoint was planned to be collected and analyzed for TP1 and TP2 only as specified in protocol.
    End point type
    Secondary
    End point timeframe
    Treatment Period 1: Day 1, Week 1; Treatment Period 2: Day 1, Week 12
    End point values
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Number of subjects analysed
    5
    5
    Units: ng*h/mL
    arithmetic mean (standard deviation)
        JNJ-73763976
    18635 ( 10983 )
    13580 ( 8598 )
        JNJ-73763924
    3342 ( 1919 )
    2466 ( 1432 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment Period 1: From Baseline (Day 1) up to Week 12; Treatment Period 2: From Week 12 up to Week 24; Follow-Up: From Week 24 up to Week 72
    Adverse event reporting additional description
    Safety analysis set included all participants who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA
    Reporting group description
    		 Subjects received JNJ-73763989 (JNJ-3989) 200 milligrams (mg) as a subcutaneous injection (SC) every 4 weeks (Q4W) along with JNJ-56136379 (JNJ-6379) 250 mg tablet once daily (QD) and nucleos(t)ide analog (NA) treatment (either entecavir [ETV] 0.5 mg, tenofovir disoproxil fumarate [TDF] 245 mg, or tenofovir alafenamide [TAF] 25 mg) QD up to 12 weeks in TP 1. Subjects enrolled until Protocol Amendment 3, also received single dose of JNJ-6379 250 mg orally as part of their study intervention. Subjects enrolled after Protocol Amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only. Subjects were assessed for eligibility criteria for PegIFN-alpha 2a at Week 12 and those who met the criteria entered TP 2.

    Reporting group title
    Follow-Up (FU) Period-nucleos(t)ide analog (NA)
    Reporting group description
    		 At Week 24, prior to follow-up period, all subjects stopped treatment with JNJ-73763989 + JNJ-56136379 + PegIFN-alpha2a. Subjects who met the protocol-defined NA treatment completion criteria (hepatitis B surface antigen [HBsAg] <10 international units/millilitre [IU/mL], and hepatitis B e antigen [HBeAg]-negative, and hepatitis B virus deoxyribonucleic acid [HBV DNA] <lower limit of quantification [LLOQ], and alanine aminotransferase [ALT] <3*Upper limit of normal [ULN]) at Week 24, stopped NA at Week 26 (that is follow up Week 2). Subjects who did not meet NA completion criteria continued NA treatment during the follow-up period up to Week 72 (that is, follow-up Week 48).

    Reporting group title
    TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Reporting group description
    		 Subjects who met the eligibility criteria for PegIFN-alpha2a (subjects who did not have disorders including but not limited to: autoimmune disorders, bone marrow suppression, hypoglycemia, hyperglycemia, diabetes mellitus) at Week 12 received combination treatment with JNJ-73763989 200 mg SC injection Q4W along with NA treatment (either ETV 0.5 mg, TDF 245 mg, or TAF 25 mg), QD up to Week 24 plus PegIFN-alpha 2a 180 micrograms (mcg) once weekly (Q1W) during TP 2. Subjects enrolled until Protocol Amendment 3, also received single dose of JNJ-6379 250 mg orally as part of their study intervention. Subjects enrolled after Protocol Amendment 3, received JNJ-3989 + PegIFN-alpha 2a + NA only.

    Serious adverse events
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA) TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 48 (0.00%)
    4 / 48 (8.33%)
    1 / 48 (2.08%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric Cancer
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Prostatitis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatic Mass
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hydronephrosis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nephrolithiasis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ureterolithiasis
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urinary Tract Infection
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TP 1:JNJ-73763989 200 mg+JNJ-56136379 250 mg+NA Follow-Up (FU) Period-nucleos(t)ide analog (NA) TP 2:JNJ-3989 200 mg+JNJ-6379 250 mg+PegIFN-alpha2a 180 mcg+NA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 48 (25.00%)
    20 / 48 (41.67%)
    35 / 48 (72.92%)
    Investigations
    Neutrophil Count Decreased
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    4 / 48 (8.33%)
         occurrences all number
    0
    0
    7
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    2
    0
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    1
    0
    3
    Headache
         subjects affected / exposed
    3 / 48 (6.25%)
    3 / 48 (6.25%)
    4 / 48 (8.33%)
         occurrences all number
    4
    3
    4
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 48 (6.25%)
    1 / 48 (2.08%)
    5 / 48 (10.42%)
         occurrences all number
    3
    1
    5
    Influenza Like Illness
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    6 / 48 (12.50%)
         occurrences all number
    0
    0
    7
    Pyrexia
         subjects affected / exposed
    2 / 48 (4.17%)
    2 / 48 (4.17%)
    15 / 48 (31.25%)
         occurrences all number
    2
    2
    18
    Injection Site Erythema
         subjects affected / exposed
    1 / 48 (2.08%)
    0 / 48 (0.00%)
    7 / 48 (14.58%)
         occurrences all number
    1
    0
    10
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    0 / 48 (0.00%)
    1 / 48 (2.08%)
    4 / 48 (8.33%)
         occurrences all number
    0
    1
    5
    Neutropenia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    4 / 48 (8.33%)
         occurrences all number
    0
    0
    6
    Leukopenia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    0
    3
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    4 / 48 (8.33%)
         occurrences all number
    0
    0
    4
    Myalgia
         subjects affected / exposed
    2 / 48 (4.17%)
    0 / 48 (0.00%)
    9 / 48 (18.75%)
         occurrences all number
    2
    0
    9
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 48 (6.25%)
    0 / 48 (0.00%)
         occurrences all number
    1
    7
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 48 (2.08%)
    3 / 48 (6.25%)
    1 / 48 (2.08%)
         occurrences all number
    1
    3
    1
    Covid-19
         subjects affected / exposed
    0 / 48 (0.00%)
    13 / 48 (27.08%)
    1 / 48 (2.08%)
         occurrences all number
    0
    13
    1
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 48 (0.00%)
    0 / 48 (0.00%)
    5 / 48 (10.42%)
         occurrences all number
    0
    0
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Dec 2021
    The purpose of this amendment was to update the criteria for post-treatment monitoring and for nucleos(t)ide analog (NA) re-treatment for subjects who discontinued NA treatment at follow-up Week 2.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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