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    Clinical Trial Results:
    A Phase 2a, Randomized, Partially-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Pharmacokinetics of Treatment With Multiple Doses of JNJ-56136379 as Monotherapy and in Combination With a Nucleos(t)ide Analog in Subjects With Chronic Hepatitis B Virus Infection

    Summary
    EudraCT number
    2017-001110-29
    Trial protocol
    GB   BE   DE   ES   PL   IT  
    Global end of trial date
    13 Aug 2020

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Aug 2021
    First version publication date
    29 Aug 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    56136379HPB2001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03361956
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 2333 CM
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, 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
    13 Aug 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Aug 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Aug 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate efficacy of 24 weeks of study treatment, in terms of changes in 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 Practices and applicable regulatory requirements. Safety evaluations were based upon the type, incidence, and severity of Treatment-emergent adverse events (TEAEs) reported throughout the study, and on changes in physical examination, vital sign measurements, clinical laboratory test results and electrocardiogram (ECG) results.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Feb 2018
    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
    Canada: 14
    Country: Number of subjects enrolled
    China: 18
    Country: Number of subjects enrolled
    Hong Kong: 1
    Country: Number of subjects enrolled
    Japan: 8
    Country: Number of subjects enrolled
    Korea, Republic of: 7
    Country: Number of subjects enrolled
    Malaysia: 8
    Country: Number of subjects enrolled
    Russian Federation: 18
    Country: Number of subjects enrolled
    Taiwan: 32
    Country: Number of subjects enrolled
    Thailand: 7
    Country: Number of subjects enrolled
    Turkey: 23
    Country: Number of subjects enrolled
    Ukraine: 10
    Country: Number of subjects enrolled
    United States: 5
    Country: Number of subjects enrolled
    Belgium: 11
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 9
    Country: Number of subjects enrolled
    Italy: 10
    Country: Number of subjects enrolled
    Poland: 18
    Country: Number of subjects enrolled
    Spain: 12
    Country: Number of subjects enrolled
    United Kingdom: 10
    Worldwide total number of subjects
    232
    EEA total number of subjects
    71
    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)
    230
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 232 subjects were enrolled and 211 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
    JNJ-56136379- 75 mg (Open label)
    Arm description
    Subjects currently not treated received 3*25 milligrams (mg) tablets of JNJ-56136379 once daily during the open label phase from Day 1 to Week 24.
    Arm type
    Experimental

    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 75 mg of JNJ-56136379 administered as 3*25 mg of JNJ-56136379 tablets once daily orally during the open-label phase.

    Arm title
    Placebo (matching JNJ-6379 75mg) + Nucleos(t)ide analog (NA)
    Arm description
    Subjects received 3 tablets of matching placebo plus 1 tablet of NA (0.5 mg entecavir [ETV] or 300 mg tenofovir disoproxil fumarate [TDF]) once daily from Day 1 to Week 24.
    Arm type
    Placebo

    Investigational medicinal product name
    Nucleos(t)ide analog (NA): ETV or TDF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single tablet of 0.5 mg ETV or 300 mg TDF once daily orally.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 3 tablets of matching placebo once daily orally.

    Arm title
    JNJ-56136379- 75 mg + NA
    Arm description
    Subjects received 3*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.
    Arm type
    Experimental

    Investigational medicinal product name
    ETV or TDF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single tablet of 0.5 mg ETV or 300 mg TDF once daily orally.

    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 75 mg of JNJ-56136379 administered as 3*25 mg of JNJ-56136379 tablets once daily orally.

    Arm title
    JNJ-56136379- 250 mg (Open label)
    Arm description
    Subjects received 2*100 mg and 2*25 mg tablets of JNJ-56136379 once daily during the open-label phase from Day 1 to Week 24.
    Arm type
    Experimental

    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 250 mg of JNJ-56136379 administered as 2*100 mg and 2*25 mg tablets of JNJ-56136379 once daily orally during the open label phase.

    Arm title
    Placebo (matching to JNJ-56136379 250 mg) + NA
    Arm description
    Subjects received 2 tablets of matching placebo plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received 4 tablets of matching placebo (2*100 mg and 2*25 mg) once daily orally.

    Investigational medicinal product name
    ETV or TDF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single tablet of 0.5 mg ETV or 300 mg TDF once daily orally.

    Arm title
    JNJ-56136379- 250 mg + NA
    Arm description
    Subjects received 2*100 mg and 2*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.
    Arm type
    Experimental

    Investigational medicinal product name
    ETV or TDF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received a single tablet of 0.5 mg ETV or 300 mg TDF once daily orally.

    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 250 mg of JNJ-56136379 administered as 2*100 mg and 2*25 mg tablets of JNJ-56136379 once daily orally.

    Number of subjects in period 1
    JNJ-56136379- 75 mg (Open label) Placebo (matching JNJ-6379 75mg) + Nucleos(t)ide analog (NA) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) Placebo (matching to JNJ-56136379 250 mg) + NA JNJ-56136379- 250 mg + NA
    Started
    28
    21
    66
    32
    22
    63
    Completed
    24
    21
    61
    28
    19
    58
    Not completed
    4
    0
    5
    4
    3
    5
         Other
    -
    -
    -
    1
    -
    -
         Physician decision
    2
    -
    -
    1
    -
    -
         Lack of efficacy
    -
    -
    1
    -
    -
    -
         Withdrawal by subject
    2
    -
    2
    -
    2
    3
         Adverse event, non-fatal
    -
    -
    1
    1
    1
    -
         Lost to follow-up
    -
    -
    1
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    JNJ-56136379- 75 mg (Open label)
    Reporting group description
    Subjects currently not treated received 3*25 milligrams (mg) tablets of JNJ-56136379 once daily during the open label phase from Day 1 to Week 24.

    Reporting group title
    Placebo (matching JNJ-6379 75mg) + Nucleos(t)ide analog (NA)
    Reporting group description
    Subjects received 3 tablets of matching placebo plus 1 tablet of NA (0.5 mg entecavir [ETV] or 300 mg tenofovir disoproxil fumarate [TDF]) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 75 mg + NA
    Reporting group description
    Subjects received 3*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 250 mg (Open label)
    Reporting group description
    Subjects received 2*100 mg and 2*25 mg tablets of JNJ-56136379 once daily during the open-label phase from Day 1 to Week 24.

    Reporting group title
    Placebo (matching to JNJ-56136379 250 mg) + NA
    Reporting group description
    Subjects received 2 tablets of matching placebo plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 250 mg + NA
    Reporting group description
    Subjects received 2*100 mg and 2*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Reporting group values
    JNJ-56136379- 75 mg (Open label) Placebo (matching JNJ-6379 75mg) + Nucleos(t)ide analog (NA) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) Placebo (matching to JNJ-56136379 250 mg) + NA JNJ-56136379- 250 mg + NA Total
    Number of subjects
    28 21 66 32 22 63 232
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0
        Adults (18-64 years)
    27 21 65 32 22 63 230
        From 65 to 84 years
    1 0 1 0 0 0 2
        85 years and over
    0 0 0 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    39.2 ± 12.06 42.5 ± 9.11 40.3 ± 11.12 37.7 ± 10.92 40.8 ± 10.06 40.5 ± 10.99 -
    Title for Gender
    Units: subjects
        Female
    9 8 20 14 6 13 70
        Male
    19 13 46 18 16 50 162

    End points

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    End points reporting groups
    Reporting group title
    JNJ-56136379- 75 mg (Open label)
    Reporting group description
    Subjects currently not treated received 3*25 milligrams (mg) tablets of JNJ-56136379 once daily during the open label phase from Day 1 to Week 24.

    Reporting group title
    Placebo (matching JNJ-6379 75mg) + Nucleos(t)ide analog (NA)
    Reporting group description
    Subjects received 3 tablets of matching placebo plus 1 tablet of NA (0.5 mg entecavir [ETV] or 300 mg tenofovir disoproxil fumarate [TDF]) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 75 mg + NA
    Reporting group description
    Subjects received 3*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 250 mg (Open label)
    Reporting group description
    Subjects received 2*100 mg and 2*25 mg tablets of JNJ-56136379 once daily during the open-label phase from Day 1 to Week 24.

    Reporting group title
    Placebo (matching to JNJ-56136379 250 mg) + NA
    Reporting group description
    Subjects received 2 tablets of matching placebo plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 250 mg + NA
    Reporting group description
    Subjects received 2*100 mg and 2*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Subject analysis set title
    Placebo + NA (Pooled)
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    This analysis set includes subjects who received tablets of matching placebo to JNJ-56136379- 75 mg and JNJ-56136379- 250 mg respectively along with 1 tablet of NA (0.5 mg entecavir [ETV] or 300 mg tenofovir disoproxil fumarate [TDF])

    Subject analysis set title
    JNJ-56136379 + NA (Pooled)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects in this analysis set included subjects from both JNJ56136379 75mg+ NA and JNJ56136379 250mg+ NA arms respectively

    Subject analysis set title
    JNJ-56136379 75mg + ETV (Currently not treated)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Currently not treated subjects in this analysis set comprised of all those who were administered JNJ-56136379 75 mg along with the nucleot/side analog- ETV

    Subject analysis set title
    JNJ-56136379 75mg + TDF (Currently not treated)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Currently not treated subjects in this analysis set comprised of all those who were administered JNJ-56136379 75 mg along with the nucleot/side analog- TDF

    Subject analysis set title
    JNJ-56136379 75mg + ETV (virologically suppressed)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Virologically- suppressed subjects in this analysis set comprised of all those who were administered JNJ-56136379 75 mg along with the nucleot/side analog- ETV

    Subject analysis set title
    JNJ-56136379 75mg + TDF (virologically suppressed)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Virologically- suppressed subjects in this analysis set comprised of all those who were administered JNJ-56136379 75 mg along with the nucleot/side analog- TDF

    Subject analysis set title
    JNJ-56136379 250 mg+ ETV (Currently not treated)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Currently not treated subjects in this analysis set comprised of all those who were administered JNJ-56136379 250 mg along with the nucleot/side analog- ETV

    Subject analysis set title
    JNJ-56136379 250 mg + TDF (Currently not treated)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Currently not treated subjects in this analysis set comprised of all those who were administered JNJ-56136379 250 mg along with the nucleot/side analog- TDF

    Subject analysis set title
    JNJ-56136379 250 mg + ETV (virologically suppressed)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Virologically- suppressed subjects in this analysis set comprised of all those who were administered JNJ-56136379 250 mg along with the nucleot/side analog- ETV

    Subject analysis set title
    JNJ-56136379 250 mg + TDF (virologically suppressed)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Virologically- suppressed subjects in this analysis set comprised of all those who were administered JNJ-56136379 250 mg along with the nucleot/side analog- TDF

    Subject analysis set title
    Placebo + ETV (virologically suppressed)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects in this analysis set received JNJ-56136379 75 mg placebo along with ETV.

    Subject analysis set title
    Placebo 75 mg + TDF (virologically suppressed)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Virologically suppressed subjects in this analysis set received placebo of JNJ-56136379 75 mg along with TDF

    Subject analysis set title
    Placebo 250 mg + TDF (virologically suppressed)
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Virologically suppressed subjects in this analysis set received placebo of JNJ-56136379 250 mg along with TDF

    Subject analysis set title
    Placebo + NA (Pooled) [Virologically Suppressed Subjects]
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    This analysis set includes virologically suppressed subjects who received tablets of matching placebo to JNJ-56136379- 75 mg and JNJ-56136379- 250 mg respectively along with 1 tablet of NA (0.5 mg entecavir [ETV] or 300 mg tenofovir disoproxil fumarate [TDF])

    Subject analysis set title
    JNJ-56136379 75mg + NA (Virologically Suppressed Subjects)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Virologically- suppressed subjects in this analysis set comprised of all those who were administered JNJ-56136379 75 mg along with the nucleot/side analog

    Subject analysis set title
    JNJ-56136379 250 mg + NA (Virologically Suppressed Subjects)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Virologically- suppressed subjects in this analysis set comprised of all those who were administered JNJ-56136379 250 mg along with the nucleot/side analog

    Subject analysis set title
    JNJ-56136379 75 mg + NA (HbeAg Positive)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects in this analysis set comprised of all HbeAg positive subjects who received JNJ-56136379 75 mg+ NA treatment

    Subject analysis set title
    JNJ-56136379 250 mg + NA (HbeAg positive)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects in this analysis set comprised of HbeAg positive subjects who received JNJ-56136379 250 mg+ NA treatment.

    Subject analysis set title
    JNJ-56136379 75 mg + NA (HbeAg negative)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects in this analysis set comprised of HbeAg negative subjects who received JNJ-56136379 75 mg + NA treatment.

    Subject analysis set title
    JNJ-56136379 250 mg + NA (HbeAg negative)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Subjects in this analysis set comprised of HbeAg negative subjects who received JNJ-56136379 250 mg + NA treatment.

    Primary: Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels at Week 24

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    End point title
    Change From Baseline in Hepatitis B Surface Antigen (HBsAg) Levels at Week 24 [1] [2]
    End point description
    Change from baseline in HBsAg levels at Week 24 was assessed. Intent-to-Treat Population (ITT) consisted of all subjects who are randomized and received at least one dose of any study agent. If a subject received a study agent other than their randomly assigned study agent, subjects would be shown in the treatment arm as randomized. Here "n" represents number of subjects evaluable for the specified category.
    End point type
    Primary
    End point timeframe
    Baseline and 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: Endpoint was descriptive in nature, no inferential analysis was performed.
    [2] - 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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    28
    66
    32
    63
    43
    Units: log10 IU per milliliter (log10 IU/mL)
    arithmetic mean (standard deviation)
        HBeAg Positive (n=21,21,8,14,13)
    -0.096 ± 0.3567
    -0.108 ± 0.2957
    -0.203 ± 0.4721
    -0.165 ± 0.4491
    -0.152 ± 0.2827
        HBeAg Negative: (n= 45,38,13,16,28)
    0.053 ± 0.2066
    0.010 ± 0.0852
    0.064 ± 0.0913
    0.090 ± 0.1190
    0.020 ± 0.0785
    No statistical analyses for this end point

    Primary: Posterior Probability of JNJ6379+NA over Placebo+NA for HBsAg Change from Baseline (log10) at Week 24 by Hepatitis B e Antigen Status for Currently not Treated Subjects

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    End point title
    Posterior Probability of JNJ6379+NA over Placebo+NA for HBsAg Change from Baseline (log10) at Week 24 by Hepatitis B e Antigen Status for Currently not Treated Subjects [3]
    End point description
    Posterior Probability of JNJ6379+NA over Placebo+NA for HBsAg change from baseline (log10) at Week 24 by Hepatitis B e antigen status for currently not Treated Subjects was analyzed using Bayesian approach.
    End point type
    Primary
    End point timeframe
    Week 24
    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: Endpoint was descriptive in nature, no inferential analysis was performed.
    End point values
    JNJ-56136379 75 mg + NA (HbeAg Positive) JNJ-56136379 250 mg + NA (HbeAg positive) JNJ-56136379 75 mg + NA (HbeAg negative) JNJ-56136379 250 mg + NA (HbeAg negative)
    Number of subjects analysed
    12
    13
    21
    20
    Units: Probability
        number (not applicable)
    0
    4.8
    0
    0
    No statistical analyses for this end point

    Primary: Posterior Probability of JNJ6379+NA over Placebo+NA for HBsAg Change from Baseline (log10) at Week 24 by Hepatitis B e Antigen Status for Virologically Suppressed Subjects

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    End point title
    Posterior Probability of JNJ6379+NA over Placebo+NA for HBsAg Change from Baseline (log10) at Week 24 by Hepatitis B e Antigen Status for Virologically Suppressed Subjects [4]
    End point description
    Posterior probability of JNJ6379+NA over Placebo+NA for HBsAg change from baseline (log10) at Week 24 by Hepatitis B e antigen status for virologically suppressed subjects was analyzed using Bayesian approach.
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [4] - 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: Endpoint was descriptive in nature, no inferential analysis was performed.
    End point values
    JNJ-56136379 75mg + NA (Virologically Suppressed Subjects) JNJ-56136379 250 mg + NA (Virologically Suppressed Subjects)
    Number of subjects analysed
    33
    30
    Units: Probability
    number (not applicable)
        HbeAg Negative
    0
    0
        HbeAg Positive
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment- emergent Adverse Events (AEs)

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    End point title
    Number of Subjects With Treatment- emergent Adverse Events (AEs) [5]
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The safety population included all subjects who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
    End point type
    Secondary
    End point timeframe
    Up to Week 80
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    28
    66
    32
    63
    43
    Units: Subjects
    18
    55
    25
    54
    34
    No statistical analyses for this end point

    Secondary: Number of Subjects With Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Serious Adverse Events (SAEs) [6]
    End point description
    A serious adverse event (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. The safety population included all subjects who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
    End point type
    Secondary
    End point timeframe
    Up to Week 80
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    28
    66
    32
    63
    43
    Units: Subjects
    0
    3
    0
    4
    1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Laboratory Findings

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    End point title
    Number of Subjects with Clinically Significant Changes in Vital Signs, Physical Examinations, Electrocardiogram (ECG), and Laboratory Findings [7]
    End point description
    Number of subjects with clinically significant changes in vital signs, physical examinations, ECG, and laboratory findings were assessed. The safety population included all subjects who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated.
    End point type
    Secondary
    End point timeframe
    Up to Week 80
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    28
    66
    32
    63
    43
    Units: Subjects
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) for Currently not Treated Subjects at Week 24

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    End point title
    Percentage of Subjects With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) for Currently not Treated Subjects at Week 24 [8]
    End point description
    Percentage of subjects with HBsAg levels less than (<) 1,000 or <100 IU/mL for currently not treated subjects at week 24 was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    28
    33
    32
    33
    22
    Units: Percentage of subjects
    number (not applicable)
        HBsAg<100 IU/mL: HBeAg positive (n=8,12,14,11,8)
    0
    0
    0
    0
    0
        HBsAg<1000 IU/mL: HBeAg positive(n=13,21,16,19,13)
    0
    0
    0
    0
    0
        HBsAg<100 IU/mL: HBeAg negative (n=13,21,16,19,13)
    0
    0
    0
    0
    0
        HBsAg<1000 IU/mL:HBeAg negative (n=13,21,16,19,13)
    23.1
    4.8
    0
    10.5
    15.4
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) for Virologically Suppressed Subjects at Week 24

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    End point title
    Percentage of Subjects With HBsAg Levels Less Than (<) 1,000 or <100 International Units Per Milliliter (IU/mL) for Virologically Suppressed Subjects at Week 24
    End point description
    Percentage of subjects with HBsAg levels less than (<) 1,000 or <100 IU/mL for virologically suppressed subjects at week 24 was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo + NA (Pooled) [Virologically Suppressed Subjects] JNJ-56136379 75mg + NA (Virologically Suppressed Subjects) JNJ-56136379 250 mg + NA (Virologically Suppressed Subjects)
    Number of subjects analysed
    21
    33
    30
    Units: Percentage of subjects
    number (not applicable)
        HBsAg<100 IU/mL: HBeAg positive (n=5,9,10)
    0
    0
    0
        HBsAg<1000 IU/mL: HBeAg positive (n=5,9,10)
    20
    11.1
    10
        HBsAg<100 IU/mL: HBeAg negative (n=15,24,19)
    0
    0
    0
        HBsAg<1000 IU/mL: HBeAg negative (n=15,24,19)
    0
    29.2
    15.8
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Greater Than (>) 0.5 log10 IU/mL Reduction in HBsAg From Baseline for Currently-not Treated Subjects at Week 24

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    End point title
    Percentage of Subjects With Greater Than (>) 0.5 log10 IU/mL Reduction in HBsAg From Baseline for Currently-not Treated Subjects at Week 24 [9]
    End point description
    Percentage of subjects with >0.5 log10 IU/mL reduction in HBsAg from baseline for currently not treated subjects at week 24 was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    8
    12
    14
    11
    8
    Units: Percentage of subjects
        number (not applicable)
    12.5
    8.3
    28.6
    36.4
    12.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Greater Than (>) 0.5 log10 IU/mL Reduction in HBsAg From Baseline for Virologically Suppressed Subjects at Week 24

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    End point title
    Percentage of Subjects With Greater Than (>) 0.5 log10 IU/mL Reduction in HBsAg From Baseline for Virologically Suppressed Subjects at Week 24
    End point description
    Percentage of subjects with >0.5 log10 IU/mL reduction in HBsAg from baseline for virologically suppressed subjects at week 24 was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo + NA (Pooled) [Virologically Suppressed Subjects] JNJ-56136379 75mg + NA (Virologically Suppressed Subjects) JNJ-56136379 250 mg + NA (Virologically Suppressed Subjects)
    Number of subjects analysed
    5
    9
    10
    Units: Percentage of subjects
        number (not applicable)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) Levels at Week 24 for Currently not Treated HbeAg Positive Subjects

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    End point title
    Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) Levels at Week 24 for Currently not Treated HbeAg Positive Subjects [10]
    End point description
    Change from baseline in HBV DNA levels at week 24 for currently not treated HBeAg positive subjects was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    8
    12
    14
    11
    8
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -3.284 ± 2.1148
    -5.531 ± 0.7915
    -5.719 ± 0.8395
    -5.883 ± 1.1396
    -5.211 ± 1.1986
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) Levels at Week 24 for Currently not Treated HbeAg Negative Subjects

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    End point title
    Change From Baseline in Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) Levels at Week 24 for Currently not Treated HbeAg Negative Subjects [11]
    End point description
    Change from baseline in HBV DNA levels at week 24 for currently not treated HBeAg negative subjects was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    16
    21
    18
    20
    14
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -3.469 ± 1.2901
    -4.077 ± 0.9435
    -3.545 ± 1.1482
    -3.690 ± 1.5289
    -3.622 ± 1.3003
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Undetectable HBV DNA Levels at Week 24 for Currently not Treated Population

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    End point title
    Percentage of Subjects With Undetectable HBV DNA Levels at Week 24 for Currently not Treated Population [12]
    End point description
    Percentage of subjects with undetectable HBV DNA levels at week 24 for currently not treated population was evaluated. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here "n" represents number of subjects evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    28
    66
    32
    63
    22
    Units: Percentage of subjects
    number (not applicable)
        HBeAg Positive (n= 12,12,14,23,8)
    0
    0
    0
    7.7
    0
        HBeAg Negative (n= 16,21,18,20,14)
    12.5
    33.3
    38.9
    35.0
    35.7
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Undetectable HBV DNA Levels at Week 24 for Virologically Suppressed Population

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    End point title
    Percentage of Subjects With Undetectable HBV DNA Levels at Week 24 for Virologically Suppressed Population
    End point description
    Percentage of subjects with undetectable HBV DNA levels at week 24 for virologically suppresed subjects was evaluated. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here "n" represents number of subjects evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo + NA (Pooled) [Virologically Suppressed Subjects] JNJ-56136379 75mg + NA (Virologically Suppressed Subjects) JNJ-56136379 250 mg + NA (Virologically Suppressed Subjects)
    Number of subjects analysed
    21
    33
    30
    Units: Percentage of subjects
    number (not applicable)
        HBeAg positive (n= 6,9,10)
    50
    66.7
    90
        HBeAg negative (n= 15,24,20)
    100
    100
    90
    No statistical analyses for this end point

    Secondary: Change From Baseline in Hepatitis B E Antigen (HBeAg) Levels for HBeAg Positive Subjects at Week 24

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    End point title
    Change From Baseline in Hepatitis B E Antigen (HBeAg) Levels for HBeAg Positive Subjects at Week 24 [13]
    End point description
    Change from baseline in HBeAg levels for HBeAg positive subjects at week 24 was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    8
    21
    14
    21
    13
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    -0.456 ± 0.2908
    -0.413 ± 0.3793
    -0.974 ± 0.8400
    -0.445 ± 0.5618
    -0.619 ± 0.7248
    No statistical analyses for this end point

    Secondary: Percentage of Subjects by HBeAg Levels Reduced from Baseline >0.5 log10 IU/mL and >1 log10 IU/mL for Currently not Treated Subjects at Week 24

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    End point title
    Percentage of Subjects by HBeAg Levels Reduced from Baseline >0.5 log10 IU/mL and >1 log10 IU/mL for Currently not Treated Subjects at Week 24 [14]
    End point description
    Percentage of subjects by HBeAg levels reduced from baseline >0.5 log10 IU/mL and >1 log10 IU/mL for currently not treated subjects at week 24 was evaluated. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    8
    12
    14
    11
    8
    Units: Percentage of subjects
    number (not applicable)
        Reduction from Baseline at Wk 24: >0.5 log10 IU/mL
    50
    41.7
    78.6
    63.6
    62.5
        Reduction from Baseline at Wk 24: >1 log10 IU/mL
    0
    8.3
    42.9
    36.4
    37.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects by HBeAg Levels Reduced from Baseline >0.5 log10 IU/mL and >1 log10 IU/mL for Virologically Suppressed Subjects at Week 24

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    End point title
    Percentage of Subjects by HBeAg Levels Reduced from Baseline >0.5 log10 IU/mL and >1 log10 IU/mL for Virologically Suppressed Subjects at Week 24
    End point description
    Percentage of subjects by HBeAg levels reduced from baseline >0.5 log10 IU/mL and >1 log10 IU/mL for virologically suppressed subjects at week 24 was evaluated. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo + NA (Pooled) [Virologically Suppressed Subjects] JNJ-56136379 75mg + NA (Virologically Suppressed Subjects) JNJ-56136379 250 mg + NA (Virologically Suppressed Subjects)
    Number of subjects analysed
    5
    9
    10
    Units: Percentage of subjects
    number (not applicable)
        Reduction from Baseline at Wk 24: >0.5 log10 IU/mL
    20
    33.3
    10
        Reduction from Baseline at Wk 24: >1 log10 IU/mL
    20
    11.1
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With HBsAg Seroclearance

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    End point title
    Number of Subjects With HBsAg Seroclearance [15]
    End point description
    Number of subjects with HBsAg seroclearance was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled) Placebo + NA (Pooled) [Virologically Suppressed Subjects] JNJ-56136379 75mg + NA (Virologically Suppressed Subjects) JNJ-56136379 250 mg + NA (Virologically Suppressed Subjects)
    Number of subjects analysed
    28
    66
    32
    63
    43
    21
    33
    30
    Units: Subjects
        Week 24
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With HBsAg Seroconversion

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    End point title
    Number of Subjects With HBsAg Seroconversion [16]
    End point description
    Number of subjects with HBsAg seroconversion was assessed. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled) Placebo + NA (Pooled) [Virologically Suppressed Subjects]
    Number of subjects analysed
    28
    66
    32
    63
    43
    21
    Units: Subjects
        Week 24
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Normalized Alanine Aminotransferase (ALT) Levels for Currently not Treated Population at Week 24

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    End point title
    Percentage of Subjects With Normalized Alanine Aminotransferase (ALT) Levels for Currently not Treated Population at Week 24 [17]
    End point description
    Percentage of subjects with normalized alanine aminotransferase (ALT) levels for currently not treated population at week 24 was assessed ,whose ALT levels were above upper limit of normal at baseline. Safety population: all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated. Here "n" represents number of subjects evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Week 24
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    23
    27
    26
    27
    18
    Units: Percentage of subjects
    number (not applicable)
        HBeAg positive (n=8,11,14,11,8)
    60
    54.5
    64.3
    44.4
    62.5
        HBeAg negative (n=15,16,12,16,10)
    91.7
    68.8
    72.7
    80
    55.6
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With Normalized Alanine Aminotransferase (ALT) Levels for Virologically Suppressed Population at Week 24

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    End point title
    Percentage of Subjects With Normalized Alanine Aminotransferase (ALT) Levels for Virologically Suppressed Population at Week 24
    End point description
    Percentage of subjects with normalized alanine aminotransferase (ALT) levels for virologically suppressed population at week 24 was assessed ,whose ALT levels were above upper limit of normal at baseline. Safety population: all participants who received at least one dose of the study agent; all safety endpoints were analyzed by the treatment arm as treated. Here "n" represents number of subjects evaluable for the specified category.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Placebo + NA (Pooled) [Virologically Suppressed Subjects] JNJ-56136379 75mg + NA (Virologically Suppressed Subjects) JNJ-56136379 250 mg + NA (Virologically Suppressed Subjects)
    Number of subjects analysed
    3
    4
    5
    Units: Percentage of subjects
    number (not applicable)
        HBeAg Positive (n= 1,1,3)
    0
    100
    33.3
        HBeAg Negative (n= 2,3,2)
    50
    100
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Virological Breakthrough

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    End point title
    Number of Subjects With Virological Breakthrough [18]
    End point description
    Number of subjects with viral breakthrough defined as confirmed on treatment HBV DNA increase by greater than (>) 1 log10 from nadir level or confirmed on treatment level >200 International Units Per Milliliter (IU/mL) in participants who had HBV DNA level below the lower limit of quantification (LLOQ) of the HBV DNA assay. Intent-to-Treat Population (ITT) consisted of all subjects who are randomized and received at least one dose of any study agent. If a subject receives a study agent other than their randomly assigned study agent, subjects will be shown in the treatment arm as randomized.
    End point type
    Secondary
    End point timeframe
    Up to Week 80
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    28
    66
    32
    63
    43
    Units: Subjects
        Viral breakthrough during 24 weeks
    5
    0
    1
    0
    0
        Breakthrough b/w 25 & 48 weeks(n=3,43,20,48,33)
    1
    1
    0
    0
    0
        Breakthrough for NA treatment (n= 24,64,29,60,40)
    0
    2
    2
    2
    1
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of Entecavir [ETV]

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    End point title
    Plasma Concentrations of Entecavir [ETV]
    End point description
    Plasma concentrations of ETV administered as monotherapy or co-administered with JNJ-56136379 was determined. The pharmacokinetic (PK) analysis set included data for all subjects with available plasma concentrations. "99999" denotes timepoints in particular arms which do not have any value.
    End point type
    Secondary
    End point timeframe
    Day1: 0 hours (h), Day 1: 2h, Week (W)1: 0h, W2:0h, W4: 0h, W8: 0h, W12: 0h, W20: 0h, W24: 0h, W28: 0h, W32: 0h, W36: 0h, W44: 0h, W48: 0h, Follow-up (FU): W2, FU: W4
    End point values
    JNJ-56136379 75mg + ETV (Currently not treated) JNJ-56136379 75mg + ETV (virologically suppressed) JNJ-56136379 250 mg+ ETV (Currently not treated) JNJ-56136379 250 mg + ETV (virologically suppressed) Placebo + ETV (virologically suppressed)
    Number of subjects analysed
    9
    15
    7
    9
    6
    Units: nanograms per milliliter (ng/ml)
    arithmetic mean (standard deviation)
        D1: 0h
    99999 ± 99999
    0.683 ± 0.414
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        D1: 2h
    1.39 ± 0.709
    1.86 ± 0.639
    1.18 ± 0.197
    1.89 ± 0.429
    99999 ± 99999
        W1: 0h
    0.321 ± 0.0961
    0.464 ± 0.143
    0.289 ± 0.0351
    0.472 ± 0.120
    1.94 ± 2.43
        W2: 0h
    0.285 ± 0.166
    0.469 ± 0.153
    0.377 ± 0.0531
    0.469 ± 0.0835
    0.871 ± 0.909
        W4: 0h
    0.417 ± 0.143
    0.529 ± 0.198
    0.414 ± 0.0742
    0.539 ± 0.108
    0.647 ± 0.628
        W8: 0h
    0.353 ± 0.226
    0.496 ± 0.179
    0.466 ± 0.0913
    0.493 ± 0.0816
    99999 ± 99999
        W12: 0h
    0.467 ± 0.188
    0.454 ± 0.135
    0.479 ± 0.0650
    0.548 ± 0.0535
    0.277 ± 0.0733
        W20: 0h
    0.441 ± 0.147
    0.617 ± 0.408
    0.481 ± 0.0625
    0.537 ± 0.109
    99999 ± 99999
        W24: 0h
    0.395 ± 0.309
    0.491 ± 0.144
    0.385 ± 0.0415
    0.576 ± 0.121
    99999 ± 99999
        W28: 0h
    99999 ± 99999
    0.446 ± 0.148
    0.527 ± 0.0302
    0.519 ± 0.153
    99999 ± 99999
        W32: 0h
    99999 ± 99999
    0.467 ± 0.201
    0.462 ± 0.0410
    0.489 ± 0.114
    99999 ± 99999
        W36: 0h
    99999 ± 99999
    0.487 ± 0.185
    0.442 ± 0.0517
    0.526 ± 0.109
    0.962 ± 1.07
        W44: 0h
    99999 ± 99999
    0.525 ± 0.177
    0.438 ± 0.0352
    0.517 ± 0.121
    99999 ± 99999
        W48: 0h
    0.434 ± 0.0968
    0.554 ± 0.287
    0.539 ± 0.0414
    0.537 ± 0.105
    0.766 ± 0.594
        FU: W2
    0.542 ± 0.311
    0.635 ± 0.449
    0.307 ± 0.176
    0.433 ± 0.117
    99999 ± 99999
        FU: W4
    0.354 ± 0.260
    0.445 ± 0.164
    0.309 ± 0.161
    0.725 ± 0.598
    1.00 ± 1.13
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of Tenofovir (TFV) for Currently not Treated and Virologically Suppressed Population

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    End point title
    Plasma Concentrations of Tenofovir (TFV) for Currently not Treated and Virologically Suppressed Population [19]
    End point description
    Plasma concentrations of TFV for currently not treated and virologically suppressed population administered as monotherapy or co-administered with JNJ-56136379 was determined. The PK analysis set included data for all subjects with available plasma concentrations. "99999" denotes timepoints in particular arms which do not have any value.
    End point type
    Secondary
    End point timeframe
    Day1: 0 hours (h), Day 1: 2h, Week (W)1: 0h, W2:0h, W4: 0h, W8: 0h, W12: 0h, W16: 0h, W20: 0h, W24: 0h, W28: 0h, W32: 0h, W36: 0h, W40: 0h, W44: 0h, W48: 0h, Follow-up (FU): W2, FU: W4
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    Placebo (matching JNJ-6379 75mg) + Nucleos(t)ide analog (NA) Placebo (matching to JNJ-56136379 250 mg) + NA JNJ-56136379 75mg + TDF (Currently not treated) JNJ-56136379 75mg + TDF (virologically suppressed) JNJ-56136379 250 mg + TDF (Currently not treated) JNJ-56136379 250 mg + TDF (virologically suppressed) Placebo 75 mg + TDF (virologically suppressed) Placebo 250 mg + TDF (virologically suppressed)
    Number of subjects analysed
    9
    8
    24
    18
    26
    21
    5
    8
    Units: nanograms per milliliter (ng/ml)
    arithmetic mean (standard deviation)
        D1: 0h
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    68.9 ± 10.1
    99999 ± 99999
    63.3 ± 27.4
    99999 ± 99999
    99999 ± 99999
        D1: 2h
    277 ± 116
    170 ± 114
    372 ± 478
    306 ± 145
    249 ± 96.9
    364 ± 260
    274 ± 153
    311 ± 92.5
        W1: 0h
    79.6 ± 38.1
    92.7 ± 134
    92.6 ± 37.4
    97.9 ± 38.0
    97.8 ± 27.7
    97.1 ± 36.8
    76.8 ± 40.8
    59.2 ± 15.7
        W2: 0h
    64.2 ± 34.5
    50.1 ± 14.1
    81.5 ± 22.6
    97.5 ± 34.0
    97.6 ± 23.7
    114 ± 51.0
    82.0 ± 53.0
    65.9 ± 18.9
        W4: 0h
    62.9 ± 17.7
    46.5 ± 10.5
    90.2 ± 25.8
    96.9 ± 25.0
    99.6 ± 26.4
    110 ± 41.4
    83.1 ± 54.8
    66.9 ± 20.3
        W8: 0h
    66.3 ± 23.7
    54.2 ± 18.3
    92.6 ± 25.7
    118 ± 48.0
    108 ± 36.0
    109 ± 32.2
    84.0 ± 54.1
    65.5 ± 28.9
        W12: 0h
    67.5 ± 31.2
    51.3 ± 15.9
    93.5 ± 29.1
    99.4 ± 33.8
    102 ± 35.3
    130 ± 87.8
    98.8 ± 73.6
    63.5 ± 21.6
        W16: 0h
    99999 ± 99999
    47.5 ± 25.4
    99999 ± 99999
    99999 ± 99999
    77.8 ± 15.0
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        W20: 0h
    72.6 ± 34.2
    51.2 ± 13.8
    85.8 ± 30.6
    120 ± 30.1
    115 ± 41.7
    127 ± 64.9
    99.6 ± 85.0
    64.8 ± 23.3
        W24: 0h
    75.9 ± 51.0
    50.5 ± 20.1
    89.1 ± 30.1
    104 ± 29.9
    99.3 ± 37.8
    113 ± 47.6
    78.3 ± 33.4
    73.8 ± 33.0
        W28: 0h
    74.4 ± 38.1
    51.2 ± 19.9
    99.0 ± 32.6
    110 ± 43.2
    108 ± 39.0
    155 ± 107
    81.7 ± 37.7
    70.6 ± 28.1
        W32: 0h
    78.8 ± 59.6
    52.7 ± 26.1
    89.6 ± 37.1
    106 ± 36.4
    88.5 ± 25.6
    139 ± 93.3
    75.5 ± 54.8
    61.2 ± 21.2
        W36: 0h
    78.9 ± 55.8
    42.5 ± 19.3
    96.0 ± 38.3
    101 ± 33.1
    101 ± 34.2
    132 ± 90.2
    80.2 ± 50.3
    80.2 ± 31.2
        W40: 0h
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        W44: 0h
    86.3 ± 30.8
    46.3 ± 26.0
    81.8 ± 38.9
    109 ± 53.4
    105 ± 33.5
    129 ± 73.6
    72.7 ± 54.9
    93.0 ± 64.2
        W48: 0h
    76.4 ± 40
    47.8 ± 18.6
    89.5 ± 49.8
    114 ± 31.7
    100 ± 29.9
    133 ± 117
    87.6 ± 58.5
    66.2 ± 22.1
        FU: W2
    73.8 ± 37.1
    52.1 ± 17.3
    65.7 ± 29.5
    73.2 ± 18.5
    73.5 ± 23.2
    136 ± 95.5
    86.5 ± 73.8
    51.9 ± 23.4
        FU: W4
    72.4 ± 32.1
    57.1 ± 13.6
    68.7 ± 54.3
    71.2 ± 33.0
    68.4 ± 43.6
    95.8 ± 83.6
    74.7 ± 47.6
    59.7 ± 23.4
    No statistical analyses for this end point

    Secondary: Plasma Concentrations of JNJ-56136379 for Currently not Treated and Virologically Suppressed Population

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    End point title
    Plasma Concentrations of JNJ-56136379 for Currently not Treated and Virologically Suppressed Population [20]
    End point description
    Plasma concentrations of JNJ-56136379 for currently not treated and virologically suppressed population administered as monotherapy or when co-administered with NA (ETV or TDF) was determined. The PK analysis set included data for all subjects with available plasma concentrations. "99999" denotes timepoints in particular arms which do not have any value.
    End point type
    Secondary
    End point timeframe
    Day1: 0 hours (h), Day 1: 2h, Week (W)1: 0h, W2:0h, W4: 0h, W8: 0h, W12: 0h, W16: 0h, W20: 0h, W24: 0h, W28: 0h, W32: 0h, W36: 0h, W40: 0h, W44: 0h, W48: 0h, Follow-up (FU): W2, FU: W4
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 250 mg (Open label) JNJ-56136379 75mg + ETV (Currently not treated) JNJ-56136379 75mg + TDF (Currently not treated) JNJ-56136379 75mg + ETV (virologically suppressed) JNJ-56136379 75mg + TDF (virologically suppressed) JNJ-56136379 250 mg+ ETV (Currently not treated) JNJ-56136379 250 mg + TDF (Currently not treated) JNJ-56136379 250 mg + ETV (virologically suppressed) JNJ-56136379 250 mg + TDF (virologically suppressed)
    Number of subjects analysed
    28
    32
    9
    24
    15
    18
    7
    26
    9
    21
    Units: nanograms per milliliter (ng/ml)
    arithmetic mean (standard deviation)
        D1: 0h
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        D1:2h
    709 ± 307
    2143 ± 1300
    520 ± 279
    820 ± 306
    857 ± 238
    616 ± 385
    2287 ± 946
    2021 ± 893
    2103 ± 1400
    2083 ± 1022
        W1: 0h
    2269 ± 597
    7339 ± 2040
    2264 ± 455
    2368 ± 695
    2144 ± 553
    2301 ± 639
    6461 ± 2014
    7138 ± 2280
    5758 ± 1081
    7280 ± 2098
        W2: 0h
    3424 ± 845
    10894 ± 2631
    3094 ± 892
    3702 ± 1028
    3193 ± 1017
    3206 ± 710
    9381 ± 2168
    10588 ± 3568
    8485 ± 2269
    10077 ± 2886
        W4: 0h
    4116 ± 941
    12827 ± 3104
    4368 ± 1216
    4697 ± 1474
    3689 ± 1178
    3694 ± 815
    10760 ± 2162
    12513 ± 4229
    10106 ± 2838
    12167 ± 4271
        W08: 0h
    4617 ± 1195
    13697 ± 3702
    5006 ± 1258
    4719 ± 1465
    3917 ± 1131
    3998 ± 1376
    11027 ± 2009
    13037 ± 4394
    11295 ± 3829
    13352 ± 6072
        W12: 0h
    4130 ± 1145
    12676 ± 3431
    4976 ± 1302
    4582 ± 1324
    4194 ± 1279
    3813 ± 945
    11347 ± 1754
    12524 ± 4756
    10404 ± 4246
    12776 ± 5191
        W16: 0h
    99999 ± 99999
    11333 ± 2639
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    12316 ± 1947
    99999 ± 99999
    99999 ± 99999
        W20: 0h
    3754 ± 1132
    12757 ± 4298
    4648 ± 1508
    4698 ± 1661
    3948 ± 1151
    4134 ± 1375
    10517 ± 2031
    11425 ± 3719
    10761 ± 3980
    12432 ± 4249
        W24: 0h
    3613 ± 813
    12626 ± 3396
    4650 ± 1461
    4767 ± 1601
    3989 ± 957
    3836 ± 1160
    10888 ± 1576
    11625 ± 5087
    10219 ± 3370
    11542 ± 4612
        W28:0h
    4733 ± 350
    12025 ± 3229
    4300 ± 1355
    4439 ± 1446
    4259 ± 1083
    3506 ± 1032
    11753 ± 2719
    11746 ± 4752
    9959 ± 2929
    11344 ± 4482
        W32: 0h
    99999 ± 99999
    12162 ± 2780
    4677 ± 646
    4825 ± 2429
    3788 ± 841
    3721 ± 1088
    9840 ± 3770
    12119 ± 4062
    10189 ± 3160
    12099 ± 6301
        W36: 0h
    99999 ± 99999
    11289 ± 2973
    4463 ± 1444
    4144 ± 1599
    3801 ± 1170
    3535 ± 964
    11350 ± 3439
    11192 ± 5191
    10036 ± 2786
    12227 ± 5396
        W40: 0h
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
    99999 ± 99999
        W44: 0h
    99999 ± 99999
    11198 ± 2749
    4507 ± 1121
    3430 ± 1346
    3998 ± 1139
    3784 ± 1056
    11570 ± 2674
    11016 ± 4277
    9634 ± 3707
    14853 ± 7977
        W48: 0h
    99999 ± 99999
    11797 ± 2482
    99999 ± 99999
    99999 ± 99999
    3918 ± 1259
    99999 ± 99999
    11220 ± 2464
    10740 ± 2400
    99999 ± 99999
    15080 ± 8060
        FU: W2
    916 ± 930
    2459 ± 1529
    1330 ± 887
    909 ± 740
    621 ± 607
    912 ± 585
    1922 ± 1628
    2192 ± 1535
    1919 ± 1359
    3190 ± 4462
        FU: W4
    242 ± 359
    494 ± 427
    320 ± 276
    226 ± 236
    89.8 ± 102
    204 ± 209
    572 ± 624
    1025 ± 1523
    389 ± 384
    1066 ± 2319
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Associated Mutations

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    End point title
    Number of Subjects With Treatment-Associated Mutations [21]
    End point description
    Viral genome sequence analysis was performed to evaluate emergence of mutations associated with JNJ-56136379 considering 15 HBV core protein positions of interest. Intent-to-treat (ITT) population: all participants who were randomized and received at least one dose of any study agent. If a participant received a study agent other than their randomly assigned study agent, participants were shown in the treatment arm as randomized. Here number of subjects analyzed corresponds to the number of subjects with paired baseline and post-baseline sequence info available.
    End point type
    Secondary
    End point timeframe
    Up to Week 80
    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: Endpoint was planned to be reported for specified arms only.
    End point values
    JNJ-56136379- 75 mg (Open label) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) JNJ-56136379- 250 mg + NA Placebo + NA (Pooled)
    Number of subjects analysed
    23
    22
    17
    14
    11
    Units: Subjects
        Emergence of mutations during 24 weeks
    8
    0
    4
    0
    0
        Emergence of mutations between 25 and 48 weeks
    2
    0
    0
    0
    0
        Emergence of mutations on NA treatment
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 104 weeks
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    23.0
    Reporting groups
    Reporting group title
    JNJ-56136379-75 mg (Open label)
    Reporting group description
    Subjects currently not treated received 3*25 milligrams (mg) tablets of JNJ-56136379 once daily during the open label phase from Day 1 to Week 24.

    Reporting group title
    Placebo (matching JNJ-6379 75 mg) + Nucleos(t)ide analog (NA)
    Reporting group description
    Subjects received 3 tablets of matching placebo plus 1 tablet of NA (0.5 mg entecavir [ETV] or 300 mg tenofovir disoproxil fumarate [TDF]) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 75 mg + NA
    Reporting group description
    Subjects received 3*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 250 mg (Open label)
    Reporting group description
    Subjects received 2*100 mg and 2*25 mg tablets of JNJ-56136379 once daily during the open-label phase from Day 1 to Week 24.

    Reporting group title
    Placebo (matching to JNJ-56136379 250 mg) + NA
    Reporting group description
    Subjects received 2 tablets of matching placebo plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Reporting group title
    JNJ-56136379- 250 mg + NA
    Reporting group description
    Subjects received 2*100 mg and 2*25 mg tablets of JNJ-56136379 plus 1 tablet of NA (0.5 mg ETV or 300 mg TDF) once daily from Day 1 to Week 24.

    Serious adverse events
    JNJ-56136379-75 mg (Open label) Placebo (matching JNJ-6379 75 mg) + Nucleos(t)ide analog (NA) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) Placebo (matching to JNJ-56136379 250 mg) + NA JNJ-56136379- 250 mg + NA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    4 / 66 (6.06%)
    0 / 32 (0.00%)
    1 / 22 (4.55%)
    4 / 63 (6.35%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Ligament Rupture
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Post-Traumatic Neck Syndrome
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lung Adenocarcinoma
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Failure Acute
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    1 / 22 (4.55%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian Haemorrhage
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protrusion
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Muscle Necrosis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    1 / 63 (1.59%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Toxic Shock Syndrome Streptococcal
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    JNJ-56136379-75 mg (Open label) Placebo (matching JNJ-6379 75 mg) + Nucleos(t)ide analog (NA) JNJ-56136379- 75 mg + NA JNJ-56136379- 250 mg (Open label) Placebo (matching to JNJ-56136379 250 mg) + NA JNJ-56136379- 250 mg + NA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    18 / 28 (64.29%)
    13 / 21 (61.90%)
    46 / 66 (69.70%)
    23 / 32 (71.88%)
    14 / 22 (63.64%)
    45 / 63 (71.43%)
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    4 / 66 (6.06%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    0
    5
    0
    0
    1
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 21 (4.76%)
    2 / 66 (3.03%)
    3 / 32 (9.38%)
    1 / 22 (4.55%)
    6 / 63 (9.52%)
         occurrences all number
    1
    1
    11
    3
    1
    11
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    2 / 66 (3.03%)
    1 / 32 (3.13%)
    1 / 22 (4.55%)
    4 / 63 (6.35%)
         occurrences all number
    1
    0
    7
    1
    1
    7
    Amylase Increased
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 21 (4.76%)
    1 / 66 (1.52%)
    1 / 32 (3.13%)
    0 / 22 (0.00%)
    3 / 63 (4.76%)
         occurrences all number
    6
    3
    1
    4
    0
    7
    Blood Creatine Phosphokinase Increased
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 21 (9.52%)
    4 / 66 (6.06%)
    1 / 32 (3.13%)
    1 / 22 (4.55%)
    1 / 63 (1.59%)
         occurrences all number
    1
    3
    5
    1
    1
    1
    Glomerular Filtration Rate Decreased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    3 / 66 (4.55%)
    3 / 32 (9.38%)
    0 / 22 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    0
    0
    3
    3
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    2 / 66 (3.03%)
    3 / 32 (9.38%)
    1 / 22 (4.55%)
    2 / 63 (3.17%)
         occurrences all number
    0
    0
    2
    3
    1
    2
    Oropharyngeal Pain
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 21 (4.76%)
    2 / 66 (3.03%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    4 / 63 (6.35%)
         occurrences all number
    2
    1
    2
    0
    0
    6
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    3 / 66 (4.55%)
    4 / 32 (12.50%)
    0 / 22 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    1
    0
    3
    6
    0
    2
    Headache
         subjects affected / exposed
    3 / 28 (10.71%)
    3 / 21 (14.29%)
    11 / 66 (16.67%)
    7 / 32 (21.88%)
    1 / 22 (4.55%)
    14 / 63 (22.22%)
         occurrences all number
    4
    3
    23
    8
    1
    22
    General disorders and administration site conditions
    Chest Discomfort
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    2 / 32 (6.25%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    0
    Fatigue
         subjects affected / exposed
    2 / 28 (7.14%)
    4 / 21 (19.05%)
    8 / 66 (12.12%)
    2 / 32 (6.25%)
    0 / 22 (0.00%)
    5 / 63 (7.94%)
         occurrences all number
    4
    4
    8
    2
    0
    7
    Influenza Like Illness
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 21 (4.76%)
    2 / 66 (3.03%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    2
    1
    2
    0
    0
    0
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 28 (3.57%)
    2 / 21 (9.52%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    1 / 22 (4.55%)
    0 / 63 (0.00%)
         occurrences all number
    1
    2
    0
    0
    1
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 21 (4.76%)
    1 / 66 (1.52%)
    1 / 32 (3.13%)
    0 / 22 (0.00%)
    5 / 63 (7.94%)
         occurrences all number
    0
    2
    1
    1
    0
    5
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 21 (4.76%)
    3 / 66 (4.55%)
    2 / 32 (6.25%)
    0 / 22 (0.00%)
    5 / 63 (7.94%)
         occurrences all number
    1
    1
    3
    2
    0
    7
    Constipation
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    3 / 32 (9.38%)
    0 / 22 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    2
    0
    1
    3
    0
    2
    Diarrhoea
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 21 (4.76%)
    4 / 66 (6.06%)
    1 / 32 (3.13%)
    0 / 22 (0.00%)
    5 / 63 (7.94%)
         occurrences all number
    2
    1
    4
    1
    0
    6
    Nausea
         subjects affected / exposed
    2 / 28 (7.14%)
    2 / 21 (9.52%)
    2 / 66 (3.03%)
    2 / 32 (6.25%)
    1 / 22 (4.55%)
    5 / 63 (7.94%)
         occurrences all number
    3
    3
    2
    2
    1
    6
    Toothache
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    5 / 66 (7.58%)
    1 / 32 (3.13%)
    0 / 22 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    0
    5
    2
    0
    2
    Hepatobiliary disorders
    Hepatic Pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 28 (7.14%)
    1 / 21 (4.76%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    5 / 63 (7.94%)
         occurrences all number
    2
    2
    1
    0
    0
    9
    Rash
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 21 (4.76%)
    4 / 66 (6.06%)
    4 / 32 (12.50%)
    0 / 22 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    0
    1
    4
    4
    0
    7
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    5 / 63 (7.94%)
         occurrences all number
    1
    0
    1
    0
    0
    5
    Back Pain
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 21 (0.00%)
    6 / 66 (9.09%)
    3 / 32 (9.38%)
    1 / 22 (4.55%)
    3 / 63 (4.76%)
         occurrences all number
    2
    0
    6
    3
    1
    3
    Musculoskeletal Pain
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    1 / 66 (1.52%)
    3 / 32 (9.38%)
    1 / 22 (4.55%)
    0 / 63 (0.00%)
         occurrences all number
    1
    0
    1
    3
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 21 (4.76%)
    2 / 66 (3.03%)
    1 / 32 (3.13%)
    0 / 22 (0.00%)
    4 / 63 (6.35%)
         occurrences all number
    1
    1
    2
    1
    0
    6
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    2 / 22 (9.09%)
    2 / 63 (3.17%)
         occurrences all number
    0
    0
    0
    0
    2
    2
    Gastroenteritis
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    2 / 32 (6.25%)
    0 / 22 (0.00%)
    2 / 63 (3.17%)
         occurrences all number
    1
    0
    0
    2
    0
    4
    Pharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 21 (4.76%)
    2 / 66 (3.03%)
    2 / 32 (6.25%)
    1 / 22 (4.55%)
    1 / 63 (1.59%)
         occurrences all number
    1
    1
    2
    2
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    5 / 21 (23.81%)
    8 / 66 (12.12%)
    4 / 32 (12.50%)
    4 / 22 (18.18%)
    10 / 63 (15.87%)
         occurrences all number
    1
    6
    10
    6
    5
    10
    Rhinitis
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    2 / 32 (6.25%)
    0 / 22 (0.00%)
    1 / 63 (1.59%)
         occurrences all number
    3
    0
    0
    2
    0
    2
    Upper Respiratory Tract Infection
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 21 (0.00%)
    11 / 66 (16.67%)
    5 / 32 (15.63%)
    2 / 22 (9.09%)
    4 / 63 (6.35%)
         occurrences all number
    2
    0
    21
    6
    3
    8
    Urinary Tract Infection
         subjects affected / exposed
    2 / 28 (7.14%)
    0 / 21 (0.00%)
    0 / 66 (0.00%)
    0 / 32 (0.00%)
    0 / 22 (0.00%)
    0 / 63 (0.00%)
         occurrences all number
    5
    0
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2017
    The overall reason for Amendment 1, considered a substantial protocol amendment and issued on 18 December 2017, was to incorporate Health Authority feedback regarding follow-up treatment and safety monitoring after the 24-week treatment period and hormonal contraceptive treatment.
    06 Mar 2018
    The overall reason for Amendment 2, considered a substantial protocol amendment and issued on 6 March 2018, was to implement the Health Authority recommendation to evaluate the effect of extended treatment on hepatitis B surface antigen (HBsAg) decline.
    20 Feb 2019
    The overall reasons for Amendment 4, considered a substantial protocol amendment and issued on 20 February 2019, were to implement an urgent safety measure based on DRC recommendations and also include a futility rule.

    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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