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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ-73763989+JNJ-56136379+Nucleos(t)ide Analog (NA) Regimen Compared to NA Alone in e Antigen-negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

    Summary
    EudraCT number
    		 2019-002674-31
    Trial protocol
    		 BE   DE   FR   PL   ES   IT  
    Global end of trial date
    09 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jun 2023
    First version publication date
    24 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    73763989PAHPB2002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04129554
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Sciences Ireland Unlimited Company
    Sponsor organisation address
    Ringaskiddy, Co. Cork, Barnahely, Ireland, P43 E773
    Public contact
    Clinical Registry Group, Janssen Sciences Ireland Unlimited Company, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Sciences Ireland Unlimited Company, 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
    09 Jun 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the study was to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by hepatitis B surface antigen (HBsAg) levels.
    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 Practice and applicable regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Germany: 12
    Country: Number of subjects enrolled
    Spain: 25
    Country: Number of subjects enrolled
    France: 21
    Country: Number of subjects enrolled
    United Kingdom: 18
    Country: Number of subjects enrolled
    Italy: 22
    Country: Number of subjects enrolled
    Poland: 23
    Worldwide total number of subjects
    130
    EEA total number of subjects
    112
    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)
    127
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 130 subjects were enrolled and randomised in the study, out of which 121 subjects completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nucleos(t)ide analog (NA)
    Arm description
    		 Subjects received matching placebo for JNJ-73763989 by subcutaneous injection once every 4 weeks, along with matching placebo for JNJ-56136379 once daily and NA treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) once daily up to 48 weeks.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo for JNJ-73763989
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received matching placebo for JNJ-73763989 once every 4 weeks up to 48 weeks.

    Investigational medicinal product name
    Placebo for JNJ-56136379
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received matching placebo for JNJ-56136379 once daily up to 48 weeks

    Investigational medicinal product name
    Entecavir (ETV) monohydrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received ETV monohydrate 0.5 milligrams (mg) once daily up to 48 weeks as NA treatment.

    Investigational medicinal product name
    Tenofovir disoproxil fumarate (TDF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received TDF 300 mg once daily up to 48 weeks as NA treatment.

    Investigational medicinal product name
    Tenofovir alafenamide (TAF)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received TAF 25 mg once daily up to 48 weeks as NA treatment.

    Arm title
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Arm description
    		 Subjects received JNJ-73763989 200 mg subcutaneously, once every 4 weeks, along with JNJ-56136379 250 mg tablet, once daily and NA treatment (either ETV, TDF, or TAF) once daily up to 48 weeks.
    Arm type
    		 Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received JNJ-73763989 200 mg once every 4 weeks up to 48 weeks.

    Investigational medicinal product name
    JNJ-56136379
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received JNJ-56136379 250 mg once daily up to 48 weeks

    Investigational medicinal product name
    ETV monohydrate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received ETV 0.5 mg once daily up to 48 weeks as NA treatment.

    Investigational medicinal product name
    TDF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received TDF 300 mg once daily up to 48 weeks as NA treatment.

    Investigational medicinal product name
    TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received TAF 25 mg once daily up to 48 weeks as NA treatment.

    Number of subjects in period 1
    		Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Started
    45
    85
    Completed
    40
    81
    Not completed
    5
    4
         Consent withdrawn by subject
    3
    4
         Unspecified
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nucleos(t)ide analog (NA)
    Reporting group description
    		 Subjects received matching placebo for JNJ-73763989 by subcutaneous injection once every 4 weeks, along with matching placebo for JNJ-56136379 once daily and NA treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) once daily up to 48 weeks.

    Reporting group title
    JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Reporting group description
    		 Subjects received JNJ-73763989 200 mg subcutaneously, once every 4 weeks, along with JNJ-56136379 250 mg tablet, once daily and NA treatment (either ETV, TDF, or TAF) once daily up to 48 weeks.

    Reporting group values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA Total
    Number of subjects
    		 45 85 130
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 44 83 127
        From 65 to 84 years
    		 1 2 3
        85 years and over
    		 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 47.4 ( 10.55 ) 45.3 ( 10.1 ) -
    Title for Gender
    Units: subjects
        Female
    		 16 27 43
        Male
    		 29 58 87

    End points

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    End points reporting groups
    Reporting group title
    Nucleos(t)ide analog (NA)
    Reporting group description
    		 Subjects received matching placebo for JNJ-73763989 by subcutaneous injection once every 4 weeks, along with matching placebo for JNJ-56136379 once daily and NA treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) once daily up to 48 weeks.

    Reporting group title
    JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Reporting group description
    		 Subjects received JNJ-73763989 200 mg subcutaneously, once every 4 weeks, along with JNJ-56136379 250 mg tablet, once daily and NA treatment (either ETV, TDF, or TAF) once daily up to 48 weeks.

    Primary: Percentage of Subjects with Hepatitis B Surface Antigen (HBsAg) Seroclearance Without Restarting NA Treatment at Week 72

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    End point title
    		 Percentage of Subjects with Hepatitis B Surface Antigen (HBsAg) Seroclearance Without Restarting NA Treatment at Week 72 [1]
    End point description
    Percentage of subjects with HBsAg seroclearance at week 72 (24 weeks after completion of all study interventions at Week 48) without restarting NA treatment was reported. Seroclearance at Week 72 of the treatment defined as a confirmed loss of HBsAg at Week 72. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed at specified timepoint only. Modified intent-to-treat (mITT) was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this end point.
    End point type
    Primary
    End point timeframe
    Week 72
    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 planned for this primary endpoint.
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    39
    79
    Units: Percentage of subjects
        number (not applicable)
    0.0
    0.0
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Treatment Emergent Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Subjects with Treatment Emergent Serious Adverse Events (SAEs) [2]
    End point description
    An AE was any untoward medical occurrence in a clinical study subject who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then). SAEs included any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the off spring of a study subject. Safety analysis set included all randomised subjects who received at least 1 dose of study drug. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this end point and 'n' (number evaluable) signifies number of subjects analysed at each specified timepoints.
    End point type
    Primary
    End point timeframe
    Up to Week 102
    Notes
    [2] - 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 planned for this primary endpoint.
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    45
    85
    Units: Percentage of subjects
        number (not applicable)
    8.9
    3.5
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Treatment Emergent Adverse Events (TEAEs)

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    End point title
    		 Percentage of Subjects with Treatment Emergent Adverse Events (TEAEs) [3]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical study subject who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then). Safety assessments included regular monitoring of hematology, blood chemistry, blood coagulation, urine analysis, urine chemistry, renal biomarkers; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. Safety analysis set included all randomised subjects who received at least 1 dose of study drug. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' (number evaluable) signifies number of subjects analysed at each specified timepoints.
    End point type
    Primary
    End point timeframe
    Up to Week 102
    Notes
    [3] - 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 planned for this primary endpoint.
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    45
    85
    Units: Percentage of subjects
        number (not applicable)
    80.0
    85.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroclearance at Week 48

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    End point title
    		 Percentage of Subjects with HBsAg Seroclearance at Week 48
    End point description
    Percentage of subjects with hepatitis B surface antigen (HBsAg) seroclearance at Week 48 were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Hepatitis B virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ)

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    End point title
    		 Percentage of Subjects with Hepatitis B virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ)
    End point description
    Percentage of subjects with HBV DNA <LLOQ (20 international units per millilitres [IU/mL]) at week 48 was reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
        number (not applicable)
    100
    97.3
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with (Sustained) Reduction, Suppression, and/or Seroclearance

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    End point title
    		 Percentage of Subjects with (Sustained) Reduction, Suppression, and/or Seroclearance
    End point description
    Percentage of subjects with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen [HBsAg] and HBV DNA) off-treatment were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Up to Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
    number (not applicable)
        HBsAg>=LLOQ HBVDNA<2000 IU/mL
    3.6
    23.9
        HBsAg>=LLOQ and HBV DNA LLOQ <= and <2000 IU/mL
    64.3
    64.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)

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    End point title
    		 Percentage of Subjects with HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)
    End point description
    Percentage of subjects with HBsAg seroclearance at Week 96 (48 weeks after stopping all study interventions at Week 48 without restarting NA treatment) was reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
        number (not applicable)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroconversion at Week 96

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    End point title
    		 Percentage of Subjects with HBsAg Seroconversion at Week 96
    End point description
    HBsAg seroconversion was defined as HBsAg seroclearance together with appearance of anti-hepatitis B surface (HBs) or anti-hepatitis e (HBe) antibodies, respectively. Percentage of subjects with HBsAg seroconversion were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Change from Baseline in HBsAg at Weeks 48, 72 and 96

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    End point title
    		 Change from Baseline in HBsAg at Weeks 48, 72 and 96
    End point description
    Change from baseline in HBsAg was reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' (number evaluable) signifies number of subjects analysed at each specified timepoints.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 48, 72, and 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    41
    81
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 48 (n=41, 76)
    -0.06 ( 0.082 )
    -1.89 ( 0.522 )
        Week 72 (n=39, 79)
    -0.25 ( 0.563 )
    -1.76 ( 0.658 )
        Week 96 (n=40, 81)
    -0.49 ( 0.783 )
    -1.46 ( 0.661 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in HBV DNA at Weeks 48, 72 and 96

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    End point title
    		 Change from Baseline in HBV DNA at Weeks 48, 72 and 96
    End point description
    Change from baseline in HBV DNA were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this end point.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 48, 72, and 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    39
    78
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Week 48 (n=39, 74)
    0.03 ( 0.123 )
    -0.06 ( 0.221 )
        Week 72 (n=36, 76)
    0.30 ( 0.736 )
    -0.02 ( 0.118 )
        Week 96 (n=38, 78)
    0.09 ( 0.319 )
    0.00 ( 0.153 )
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Levels Greater Than (>) 1 log10 IU/mL Decline From Baseline

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    End point title
    		 Percentage of Subjects with HBsAg Levels Greater Than (>) 1 log10 IU/mL Decline From Baseline
    End point description
    Percentage of subjects with HBsAg Levels >1 log10 IU/mL decline from baseline were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    40
    81
    Units: Percentage of subjects
        number (not applicable)
    12.5
    81.5
    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 was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint. Here, '99999' indicated that since there were only less number of events reported therefore, the median survival time was not estimable.
    End point type
    Secondary
    End point timeframe
    Up to Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    83
    Units: Days
        median (full range (min-max))
    99999 (99999 to 99999)
    99999 (99999 to 99999)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96

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    End point title
    		 Percentage of Subjects with HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96
    End point description
    Percentage of subjects with HBsAg Levels <100 IU/mL at different timepoints were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Weeks 48, 72, and 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
    number (not applicable)
        Week 48 (n=41, 76)
    2.4
    71.1
        Week 72 (n=39, 79)
    10.3
    67.1
        Week 96 (n=40, 81)
    15.0
    46.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBV DNA Levels Less Than (<) LLOQ

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    End point title
    		 Percentage of Subjects with HBV DNA Levels Less Than (<) LLOQ
    End point description
    Percentage of Subjects with HBV DNA levels <LLOQ were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    28
    71
    Units: Percentage of subjects
        number (not applicable)
    3.6
    23.9
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Flares

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    End point title
    		 Percentage of Subjects with Flares
    End point description
    Percentage of subjects with flares (virologic, biochemical and clinical flares) were reported. Biochemical flare was defined as confirmed alanine transaminase flare and/or aspartate aminotransferase flare >=3*upper limit of normal and >=3*nadir. Virologic flare was defined per Derivation 1 (2 consecutive visits) HBV DNA >peak threshold in subjects who were off-treatment and had HBV DNA <LLOQ at the last observed time point on all study interventions and per Derivation 2 (2 consecutive visits) HBV DNA >peak threshold in subjects who were off-treatment and had HBVDNA >=LLOQ at the last observed time point on all study interventions. Clinical flare was defined as subjects with both virologic and biochemical flare. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
    number (not applicable)
        Virologic Flare (HBV DNA > 200 - =<2000 IU/mL)
    25.0
    38.7
        Virologic Flare (HBV DNA>2000 - =< 20000 IU/mL)
    30.0
    24.0
        Virologic Flare (HBV DNA >20000 - =<100000 IU/mL)
    10.0
    8.0
        Virologic Flare (HBV DNA >100000 IU/mL)
    27.5
    2.7
        Alanine Transaminase Flare
    19.5
    3.9
        Aspartate Aminotransferase Flare
    14.6
    1.3
        Biochemical Flare
    19.5
    3.9
        Clinical Flare: HBV DNA > 200 - =<2000IU/mL
    0.0
    0.0
        Clinical Flare: HBV DNA > 2000 - =<20000IU/mL
    0.0
    1.3
        Clinical Flare: HBV DNA > 20000 - =<100000IU/mL
    0.0
    1.3
        Clinical Flare: HBV DNA > 100000 IU/mL
    27.5
    1.3
    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 defined as confirmed on-treatment HBV DNA increase by greater than (>) 1 log10 IU/mL from nadir level or confirmed on treatment level >200 IU/mL in subjects who had HBV DNA level below <LLOQ of the HBV DNA assay were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
        number (not applicable)
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Requiring NA Re-Treatment During Follow-up

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    End point title
    		 Percentage of Subjects Requiring NA Re-Treatment During Follow-up
    End point description
    Percentage of subjects requiring NA re-treatment during follow-up were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Percentage of subjects
        number (not applicable)
    26.8
    9.1
    No statistical analyses for this end point

    Secondary: Correlation Coefficient Between On-treatment HBsAg Change from Baseline with On-treatment HBV Blood Markers and Baseline Characteristics

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    End point title
    		 Correlation Coefficient Between On-treatment HBsAg Change from Baseline with On-treatment HBV Blood Markers and Baseline Characteristics
    End point description
    Correlation coefficient between on-treatment HBsAg change from baseline with on-treatment HBV blood markers and baseline characteristics were reported. HBsAg change from baseline at FU Week 24 were analysed against age, baseline NA treatment duration, HBsAg value at baseline, HBsAg change from baseline at Week 24, and HBsAg change from baseline at Week 48. Here, baseline is specified as 'bs', duration as 'du', change as 'chn' and week 'wk'. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Baseline to Week 96
    End point values
    		 Nucleos(t)ide analog (NA) JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    44
    84
    Units: Ratio
    number (not applicable)
        HBsAg chn from bs vs Age (n=39, 79)
    0.1746
    0.2860
        HBsAg chn from bs vs bs NA treatment du (n=39,78)
    0.4324
    0.2381
        HBsAg chn from bs vs HBsAg value at bs (n=39, 79)
    -0.5923
    -0.9970
        HBsAg chn from bs at FU Wk 48 vs Wk 24(n=39, 74)
    0.7120
    0.9983
        HBsAg chn from bs at FU Wk 48 vs Wk 48 (n=39, 74)
    0.8065
    0.9982
    No statistical analyses for this end point

    Secondary: Maximum Observed Analyte Concentration (Cmax) of Dose Normalized to 1 mg (Cmax[Dose Normalised]) of JNJ-73763976

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    End point title
    		 Maximum Observed Analyte Concentration (Cmax) of Dose Normalized to 1 mg (Cmax[Dose Normalised]) of JNJ-73763976 [4]
    End point description
    Cmax(Dose Normalised) was defined as the maximum observed analyte concentration of JNJ-73763976 dose normalized to 1 mg. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: ng/mL/mg
        arithmetic mean (standard deviation)
    8.34 ( 5.37 )
    No statistical analyses for this end point

    Secondary: Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h (AUC[0-24h]) of JNJ-73763976

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    End point title
    		 Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h (AUC[0-24h]) of JNJ-73763976 [5]
    End point description
    AUC(0-24h) was defined as the area under the analyte concentration versus time curve from time 0 to 24 h of JNJ-73763976. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    24 hours postdose
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    17
    Units: nanogram*hour/millilitre (ng*h/mL)
        arithmetic mean (standard deviation)
    17833 ( 9670 )
    No statistical analyses for this end point

    Secondary: Observed Concentration at 24 h Postdose (C[24h]) of JNJ-73763976

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    End point title
    		 Observed Concentration at 24 h Postdose (C[24h]) of JNJ-73763976 [6]
    End point description
    C(24h) was defined as the observed concentration at 24 h postdose of JNJ-73763976. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    24 hours postdose
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: ng/mL
        arithmetic mean (standard deviation)
    275 ( 161 )
    No statistical analyses for this end point

    Secondary: Observed Concentration at Predose (C[predose]) of JNJ-73763976

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    End point title
    		 Observed Concentration at Predose (C[predose]) of JNJ-73763976 [7]
    End point description
    C(predose) was defined as the observed concentration at predose of JNJ-73763976. Pharmacokinetic (PK) analysis set was defined as subjects 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. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint. NA was tenofovir disoproxil fumarate (TDF). Here, '99999'' indicated that data was below quantification limit (<2.1 ng/mL).
    End point type
    Secondary
    End point timeframe
    Predose
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: nanogram/millilitre (ng/mL)
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976

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    End point title
    		 Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 [8]
    End point description
    Cmax was defined as the maximum concentration of JNJ-73763976. PK analysis set included subjects 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. NA was TDF. Here, 'N' (number analysed) signifies number of subjects analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: ng/mL
        arithmetic mean (standard deviation)
    1111 ( 716 )
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-73763976

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    End point title
    		 Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-73763976 [9]
    End point description
    tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763976. PK analysis set included subjects 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. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this outcome measure. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: Hour
        median (full range (min-max))
    6.00 (1.00 to 10.00)
    No statistical analyses for this end point

    Secondary: Observed Concentration at Predose (C[predose]) of JNJ-73763924

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    End point title
    		 Observed Concentration at Predose (C[predose]) of JNJ-73763924 [10]
    End point description
    C(predose) was defined as the observed concentration at predose of JNJ-73763924. PK analysis set was defined as subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed at each specified endpoint. NA was tenofovir disoproxil fumarate (TDF). Here, '99999'' indicates that data was below quantification limit (<2.1 ng/mL).
    End point type
    Secondary
    End point timeframe
    Predose
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: ng/mL
        arithmetic mean (standard deviation)
    99999 ( 99999 )
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-73763924

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    End point title
    		 Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-73763924 [11]
    End point description
    tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763924. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sampl6e drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: Hour
        median (full range (min-max))
    5.07 (1.00 to 8.03)
    No statistical analyses for this end point

    Secondary: Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924

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    End point title
    		 Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 [12]
    End point description
    Cmax was defined as the maximum concentration of JNJ-73763924. PK analysis set included subjects 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. NA was TDF. Here, 'N' (number analysed) signifies number of subjects analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: ng/mL
        arithmetic mean (standard deviation)
    222 ( 142 )
    No statistical analyses for this end point

    Secondary: Maximum Observed Analyte Concentration (Cmax) of Dose Normalized to 1 mg (Cmax[Dose Normalised]) of JNJ-73763924

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    End point title
    		 Maximum Observed Analyte Concentration (Cmax) of Dose Normalized to 1 mg (Cmax[Dose Normalised]) of JNJ-73763924 [13]
    End point description
    Cmax(Dose Normalised) was defined as the maximum observed analyte concentration of JNJ-73763924 dose normalized to 1 mg. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    18
    Units: nanogram/milliliter/milligram (ng/mL/mg)
        arithmetic mean (standard deviation)
    3.33 ( 2.14 )
    No statistical analyses for this end point

    Secondary: Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h (AUC[0-24h]) of JNJ-73763924

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    End point title
    		 Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h (AUC[0-24h]) of JNJ-73763924 [14]
    End point description
    AUC(0-24h) was defined as the area under the analyte concentration versus time curve from time 0 to 24 h of JNJ-73763924. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    24 hour postdose
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    17
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    3386 ( 1930 )
    No statistical analyses for this end point

    Secondary: Observed Concentration at 24 h Postdose (C[24h]) of JNJ-73763924

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    End point title
    		 Observed Concentration at 24 h Postdose (C[24h]) of JNJ-73763924 [15]
    End point description
    C(24h) was defined as the observed concentration at 24 h postdose of JNJ-73763924. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    24 hour postdose
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    17
    Units: ng/mL
        arithmetic mean (standard deviation)
    35.0 ( 25.5 )
    No statistical analyses for this end point

    Secondary: Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h of Dose Normalized to 1 mg (AUC[0-24h], Dose Normalised) of JNJ-73763976

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    End point title
    		 Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h of Dose Normalized to 1 mg (AUC[0-24h], Dose Normalised) of JNJ-73763976 [16]
    End point description
    AUC([0-24h], Dose Normalised) was defined as the area under the analyte concentration versus time curve from time 0 to 24 h of JNJ-73763976 dose normalized to 1 mg. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    17
    Units: ng*h/mL/mg
        arithmetic mean (standard deviation)
    134 ( 72.5 )
    No statistical analyses for this end point

    Secondary: Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-56136379

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    End point title
    		 Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-56136379 [17]
    End point description
    tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-56136379. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    12
    Units: Hour
        median (full range (min-max))
    4.00 (0.0 to 24.17)
    No statistical analyses for this end point

    Secondary: Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379

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    End point title
    		 Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379 [18]
    End point description
    AUCtau was defined as the area under the analyte concentration versus time curve during a dosing interval at steady state of JNJ-56136379. PK analysis set included subjects who have received at least 1 dose of any of the study interventions and have at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    12
    Units: ng*h/mL
        arithmetic mean (standard deviation)
    282458 ( 79118 )
    No statistical analyses for this end point

    Secondary: Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379

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    End point title
    		 Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379 [19]
    End point description
    Ctau was defined as the observed or predicted concentration at the end of a dosing interval of JNJ-56136379. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    11
    Units: ng/mL
        arithmetic mean (standard deviation)
    12763 ( 4959 )
    No statistical analyses for this end point

    Secondary: Observed Concentration at Predose (C[predose]) of JNJ-56136379

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    End point title
    		 Observed Concentration at Predose (C[predose]) of JNJ-56136379 [20]
    End point description
    C(predose) was defined as the observed concentration at predose of JNJ-56136379. PK analysis set was defined as subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed at each specified end point. NA was tenofovir disoproxil fumarate (TDF).
    End point type
    Secondary
    End point timeframe
    Predose
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    12
    Units: ng/mL
        arithmetic mean (standard deviation)
    10812 ( 2430 )
    No statistical analyses for this end point

    Secondary: Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h of Dose Normalized to 1 mg (AUC[0-24h], Dose Normalised) of JNJ-73763924

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    End point title
    		 Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h of Dose Normalized to 1 mg (AUC[0-24h], Dose Normalised) of JNJ-73763924 [21]
    End point description
    AUC([0-24h], Dose Normalised) was defined as the area under the analyte concentration versus time curve from time 0 to 24 h of JNJ-73763924 dose normalized to 1 mg. PK analysis set included subjects 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. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    17
    Units: ng*h/mL/mg
        arithmetic mean (standard deviation)
    50.8 ( 28.9 )
    No statistical analyses for this end point

    Secondary: Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379

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    End point title
    		 Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379 [22]
    End point description
    Cmax was defined as the maximum concentration of JNJ-56136379. PK analysis set included subjects 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. NA was TDF. Here, 'N' (number analysed) signifies number of subjects analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Up to Day 337
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This endpoint was planned to be analysed for specified arms only.
    End point values
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Number of subjects analysed
    12
    Units: ng/mL
        arithmetic mean (standard deviation)
    14754 ( 4318 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Week 102 (including 6 weeks of screening)
    Adverse event reporting additional description
    The safety analysis set included all subjects who received at least 1 dose of study drug.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
    Reporting group description
    		 Subjects received JNJ-73763989 200 mg, subcutaneously, every 4 weeks, along with JNJ-56136379 250 mg, tablet, once daily and NA treatment (either ETV, TDF, or TAF) once daily up to 48 weeks.

    Reporting group title
    Nucleos(t)ide Analog (NA)
    Reporting group description
    		 Subjects received matching placebo for JNJ-73763989 subcutaneously injection once every 4 weeks, with matching placebo for JNJ-56136379 once daily and NA treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) once daily up to 48 weeks.

    Serious adverse events
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA Nucleos(t)ide Analog (NA)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 85 (3.53%)
    4 / 45 (8.89%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Hepatic Cancer
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholangiocarcinoma
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatocellular Carcinoma
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Radius Fracture
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Subacute Hepatic Failure
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Disorder
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Covid-19
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus Infection Reactivation
         subjects affected / exposed
    1 / 85 (1.18%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis B Reactivation
         subjects affected / exposed
    0 / 85 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA Nucleos(t)ide Analog (NA)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    67 / 85 (78.82%)
    34 / 45 (75.56%)
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    6 / 85 (7.06%)
    11 / 45 (24.44%)
         occurrences all number
    23
    20
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    3 / 85 (3.53%)
    4 / 45 (8.89%)
         occurrences all number
    9
    10
    Hepatitis B DNA increased
         subjects affected / exposed
    2 / 85 (2.35%)
    3 / 45 (6.67%)
         occurrences all number
    2
    3
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    18 / 85 (21.18%)
    4 / 45 (8.89%)
         occurrences all number
    30
    5
    Vascular disorders
    Hypertension
         subjects affected / exposed
    11 / 85 (12.94%)
    3 / 45 (6.67%)
         occurrences all number
    12
    3
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 85 (22.35%)
    10 / 45 (22.22%)
         occurrences all number
    26
    14
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    12 / 85 (14.12%)
    4 / 45 (8.89%)
         occurrences all number
    15
    4
    Fatigue
         subjects affected / exposed
    11 / 85 (12.94%)
    5 / 45 (11.11%)
         occurrences all number
    18
    6
    Pyrexia
         subjects affected / exposed
    8 / 85 (9.41%)
    3 / 45 (6.67%)
         occurrences all number
    9
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    7 / 85 (8.24%)
    3 / 45 (6.67%)
         occurrences all number
    7
    4
    Diarrhoea
         subjects affected / exposed
    3 / 85 (3.53%)
    6 / 45 (13.33%)
         occurrences all number
    3
    7
    Abdominal Pain
         subjects affected / exposed
    2 / 85 (2.35%)
    3 / 45 (6.67%)
         occurrences all number
    2
    3
    Vomiting
         subjects affected / exposed
    6 / 85 (7.06%)
    1 / 45 (2.22%)
         occurrences all number
    9
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 85 (5.88%)
    1 / 45 (2.22%)
         occurrences all number
    5
    1
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 85 (1.18%)
    4 / 45 (8.89%)
         occurrences all number
    1
    4
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    10 / 85 (11.76%)
    5 / 45 (11.11%)
         occurrences all number
    12
    7
    Arthralgia
         subjects affected / exposed
    9 / 85 (10.59%)
    9 / 45 (20.00%)
         occurrences all number
    12
    13
    Muscle Spasms
         subjects affected / exposed
    1 / 85 (1.18%)
    3 / 45 (6.67%)
         occurrences all number
    1
    4
    Myalgia
         subjects affected / exposed
    6 / 85 (7.06%)
    3 / 45 (6.67%)
         occurrences all number
    7
    3
    Osteoarthritis
         subjects affected / exposed
    0 / 85 (0.00%)
    3 / 45 (6.67%)
         occurrences all number
    0
    3
    Pain in Extremity
         subjects affected / exposed
    9 / 85 (10.59%)
    2 / 45 (4.44%)
         occurrences all number
    11
    2
    Infections and infestations
    Covid-19
         subjects affected / exposed
    17 / 85 (20.00%)
    4 / 45 (8.89%)
         occurrences all number
    18
    4
    Tooth Infection
         subjects affected / exposed
    0 / 85 (0.00%)
    4 / 45 (8.89%)
         occurrences all number
    0
    5
    Nasopharyngitis
         subjects affected / exposed
    10 / 85 (11.76%)
    5 / 45 (11.11%)
         occurrences all number
    10
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Sep 2019
    The purpose of the amendment was to include the following changes: methods for handling of missing data, the exclusion criterion on allergies was broadened to also include placebo content, a reference to the prescribing information of ETV, TDF, and TAF was added, unblinding wording was updated to emphasize subject safety, and a more general recommendation to consider alternative concomitant medications or adjusted doses was provided.
    20 Jan 2020
    The purpose of the amendment was to include the following main changes: additional information for the management of hematologic abnormalities was provided and the preclinical section was updated to include the preliminary results from the 3-month combination toxicity study with JNJ-3989 and JNJ-6379.
    30 Sep 2021
    The purpose of the amendment was to include an additional NA re-treatment criterion as an urgent safety measure, after the report of a severe hepatitis B reactivation requiring liver transplantation following NA treatment discontinuation in a subject in the control arm.

    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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