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

    Summary
    EudraCT number
    2021-002450-81
    Trial protocol
    ES   PL  
    Global end of trial date
    29 Dec 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    12 Jan 2023
    First version publication date
    12 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    73763989PAHPB2007
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT05005507
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen Research & Development, LLC
    Sponsor organisation address
    920 US Highway 202, Raritan, NJ, United States, 08869-1420
    Public contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Dec 2021
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the efficacy in terms of hepatitis B surface antigen (HBsAg) changes from baseline for the treatment regimens of 24 weeks of JNJ-73763989 (JNJ-3989) + 24 weeks of nucleos(t)ide analog (NA) + 12 or 24 weeks of pegylated interferon alpha-2a (PegIFN-alpha-2a) (with immediate or delayed start of PegIFN-alpha-2a treatment), as compared to NA standard of care treatment.
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    03 Nov 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Only 1 subject was enrolled in the study in Arm 1: JNJ-73763989 + nucleos(t)ide analog (NA) + pegylated interferon alpha-2a (PegIFN-alpha-2a). Subjects were also planned to be enrolled in Arms 2 and 3 but were not enrolled as the study discontinued prematurely based on a strategic decision and not for safety reasons. None completed the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded

    Arms
    Arm title
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Arm description
    Subject received JNJ-73763989 200 milligrams (mg) subcutaneous (SC) injection on Day 1 plus NA treatment (entecavir [ETV] 0.5 mg tablet) orally once daily from Day 1 to Day 16 plus pegylated interferon alpha-2a (PegIFN-alpha-2a) 180 micrograms (mcg) SC injection on Days 1, 8, and 15.
    Arm type
    Experimental

    Investigational medicinal product name
    JNJ-73763989
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    JNJ-73763989 200 mg injection was administered subcutaneously on Day 1.

    Investigational medicinal product name
    PegIFN-alpha-2a
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    PegIFN-alpha-2a 180 mcg injection was administered subcutaneously on Days 1, 8, and 15.

    Investigational medicinal product name
    Entecavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    NA treatment entecavir (ETV) 0.5 mg tablet was administered orally once daily from Day 1 to Day 16.

    Number of subjects in period 1
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Started
    1
    Completed
    0
    Not completed
    1
         Premature discontinuation of study
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Reporting group description
    Subject received JNJ-73763989 200 milligrams (mg) subcutaneous (SC) injection on Day 1 plus NA treatment (entecavir [ETV] 0.5 mg tablet) orally once daily from Day 1 to Day 16 plus pegylated interferon alpha-2a (PegIFN-alpha-2a) 180 micrograms (mcg) SC injection on Days 1, 8, and 15.

    Reporting group values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a Total
    Number of subjects
    1 1
    Age Categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    0 0
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    1 1
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    46 ± 0 -
    Gender Categorical
    Units: Subjects
        Female
    0 0
        Male
    1 1

    End points

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    End points reporting groups
    Reporting group title
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Reporting group description
    Subject received JNJ-73763989 200 milligrams (mg) subcutaneous (SC) injection on Day 1 plus NA treatment (entecavir [ETV] 0.5 mg tablet) orally once daily from Day 1 to Day 16 plus pegylated interferon alpha-2a (PegIFN-alpha-2a) 180 micrograms (mcg) SC injection on Days 1, 8, and 15.

    Primary: Percentage of Subjects with a Reduction of at least 2log10 International Units Per Millilitre (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline at Week 24 (End of Study Intervention [EOSI])

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    End point title
    Percentage of Subjects with a Reduction of at least 2log10 International Units Per Millilitre (IU/mL) in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline at Week 24 (End of Study Intervention [EOSI]) [1]
    End point description
    Percentage of subjects with a reduction of at least 2log10 IU/mL in HBsAg levels from baseline at Week 24 (EOSI) were reported. Full analysis set (FAS) included all subjects who were randomly assigned to an intervention arm in the intervention-specific appendix (ISA) and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
    End point type
    Primary
    End point timeframe
    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: Descriptive statistics was done, no inferential statistical analysis was performed.
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [2]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [2] - This endpoint was not assessed due to premature termination of the study prior to Week 24.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Adverse Events (AEs)

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    End point title
    Percentage of Subjects with Adverse Events (AEs)
    End point description
    An AE was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Up to 1 month 26 days
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    1
    Units: Percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Serious Adverse Events (SAEs)

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    End point title
    Percentage of Subjects with Serious Adverse Events (SAEs)
    End point description
    SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Up to 1 month 26 days
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    1
    Units: Percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in Clinical Laboratory Tests

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    End point title
    Percentage of Subjects with Abnormalities in Clinical Laboratory Tests
    End point description
    Percentage of subjects with abnormalities in clinical laboratory tests including hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, renal biomarkers) were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Up to 1 month 26 days
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    1
    Units: percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in 12-Lead Electrocardiograms (ECGs)

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    End point title
    Percentage of Subjects with Abnormalities in 12-Lead Electrocardiograms (ECGs)
    End point description
    Percentage of subjects with abnormalities in 12-Lead ECGs were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Up to 1 month 26 days
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    1
    Units: Percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in Vital Signs

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    End point title
    Percentage of Subjects with Abnormalities in Vital Signs
    End point description
    Percentage of subjects with abnormalities in vital signs were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Up to 1 month 26 days
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    1
    Units: Percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in Ophthalmologic Examination

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    End point title
    Percentage of Subjects with Abnormalities in Ophthalmologic Examination
    End point description
    Percentage of subjects with abnormalities in ophthalmologic examination were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Weeks 8 and 20
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [3]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [3] - This endpoint was not assessed due to premature termination of the study prior to Weeks 8 and 20.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Abnormalities in Physical Examination

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    End point title
    Percentage of Subjects with Abnormalities in Physical Examination
    End point description
    Percentage of subjects with abnormalities in physical examination were reported. Safety analysis set included all subjects who received at least 1 dose of study intervention within the ISA. Subjects were analysed according to the study intervention they actually received.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [4]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [4] - This endpoint was not assessed due to premature termination of the study prior to Week 24.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Meeting the Protocol- defined Nucleos(t)ide Analog (NA) Treatment Completion Criteria Based on the Week 24 (EOSI) or Follow-up (FU) Week 2 Results

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    End point title
    Percentage of Subjects Meeting the Protocol- defined Nucleos(t)ide Analog (NA) Treatment Completion Criteria Based on the Week 24 (EOSI) or Follow-up (FU) Week 2 Results
    End point description
    Percentage of subjects meeting the protocol- defined NA treatment completion criteria based on the Week 24 (EOSI) or FU Week 2 results were reported. NA treatment completion criteria were as follows: (a) subject had ALT <3*upper limits of normal (ULN); (b) subject had HBV DNA <20 IU/mL; (c) subject was HBeAg-negative; (d) subject had HBsAg <10 International units per milliliter (IU/mL). FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Week 24 (EOSI) and FU Week 2
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [5]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [5] - Endpoint was not assessed due to premature termination of study prior Week 24 (EOSI) and FU Week 2.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroclearance at FU Weeks 24 and 48 without Re-starting NA Treatment

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    End point title
    Percentage of Subjects with HBsAg Seroclearance at FU Weeks 24 and 48 without Re-starting NA Treatment
    End point description
    Percentage of subjects with HBsAg seroclearance at FU Weeks 24 and 48 without re-starting NA treatment were reported. Seroclearance of HBsAg is defined as a (quantitative) HBsAg level <LLOQ. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Follow-up Weeks 24 and 48
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [6]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [6] - This endpoint was not assessed due to premature termination of study prior to FU Weeks 24 and 48.
    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) at FU Weeks 24 and 48 Without Re-starting NA Treatment

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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) at FU Weeks 24 and 48 Without Re-starting NA Treatment
    End point description
    Percentage of subjects with HBV DNA <LLOQ at FU Weeks 24 and 48 without re-starting NA treatment were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    FU Weeks 24 and 48
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [7]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [7] - This endpoint was not assessed due to premature termination of study prior to FU Weeks 24 and 48.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Virologic Flares

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    End point title
    Percentage of Subjects with Virologic Flares
    End point description
    Percentage of subjects with virologic flares were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Up to 1 month 26 days
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    1
    Units: Percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Biochemical Flares

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    End point title
    Percentage of Subjects with Biochemical Flares
    End point description
    Percentage of subjects with biochemical flares were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Up to 1 month 26 days
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    1
    Units: Percentage of subjects
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Requiring NA Re-treatment

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    End point title
    Percentage of Subjects Requiring NA Re-treatment
    End point description
    Percentage of subjects requiring NA re-treatment were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [8]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [8] - This endpoint was not assessed due to premature termination of the study prior to 72 weeks.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs Over Time

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    End point title
    Percentage of Subjects with HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs Over Time
    End point description
    Percentage of subjects with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [9]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [9] - This endpoint was not assessed due to premature termination of the study prior to 72 weeks.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with HBsAg Seroconversion

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    End point title
    Percentage of Subjects with HBsAg Seroconversion
    End point description
    Percentage of subjects with HBsAg seroconversion were reported. Seroconversion of HBsAg is defined as having achieved HBsAg seroclearance and appearance of anti-HBs antibodies. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analyzed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [10]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [10] - This endpoint was not performed due to premature termination of the study prior to 72 weeks.
    No statistical analyses for this end point

    Secondary: Change from Baseline in HBsAg Over Time

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    End point title
    Change from Baseline in HBsAg Over Time
    End point description
    Change from baseline in HBsAg over time were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Baseline up to Week 72
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [11]
    Units: IU/mL
        arithmetic mean (standard deviation)
    ±
    Notes
    [11] - This endpoint was not assessed due to premature termination of the study prior to Week 72.
    No statistical analyses for this end point

    Secondary: Time to Achieve HBsAg Seroclearance/ Seroconversion

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    End point title
    Time to Achieve HBsAg Seroclearance/ Seroconversion
    End point description
    Time to achieve HBsAg seroclearance/ seroconversion were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [12]
    Units: hours
        median (full range (min-max))
    ( to )
    Notes
    [12] - This endpoint was not performed due to premature termination of the study prior to 72 weeks.
    No statistical analyses for this end point

    Secondary: Time to Achieve HBV DNA <LLOQ

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    End point title
    Time to Achieve HBV DNA <LLOQ
    End point description
    Time to achieve HBV DNA <LLOQ were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Up to 72 weeks
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [13]
    Units: hours
        median (full range (min-max))
    ( to )
    Notes
    [13] - This endpoint was not assessed due to premature termination of the study prior to 72 weeks.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Virologic Breakthrough

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    End point title
    Percentage of Subjects with Virologic Breakthrough
    End point description
    Percentage of subjects with virologic breakthrough were reported. FAS included all subjects who were randomly assigned to an intervention arm in the ISA and received at least 1 dose of study intervention. Subjects were analysed according to the study intervention they were randomly assigned to.
    End point type
    Secondary
    End point timeframe
    Up to Week 24
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [14]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [14] - This endpoint was not assessed due to premature termination of the study prior to Week 24.
    No statistical analyses for this end point

    Secondary: Serum Concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976)

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    End point title
    Serum Concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976)
    End point description
    Serum concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976) were reported. Pharmacokinetics (PK) analysis set included all subjects who received at least 1 dose of study intervention and have at least 1 valid blood sample drawn for PK analysis.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 85, 113, 169
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [15]
    Units: nanograms per millilitre (ng/mL)
        arithmetic mean (standard deviation)
    ±
    Notes
    [15] - This endpoint was not assessed due to premature termination of the study.
    No statistical analyses for this end point

    Secondary: Serum Concentration of NA (Entecavir [ETV])

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    End point title
    Serum Concentration of NA (Entecavir [ETV])
    End point description
    Serum concentration of NA (ETV) were reported. PK analysis set included all subjects who received at least 1 dose of study intervention and have at least 1 valid blood sample drawn for PK analysis.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 85, 113, 169
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [16]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    Notes
    [16] - This endpoint was not assessed due to premature termination of the study.
    No statistical analyses for this end point

    Secondary: Serum Concentration of PegIFN-alpha-2a

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    End point title
    Serum Concentration of PegIFN-alpha-2a
    End point description
    Serum concentration of PegIFN-alpha-2a were reported. PK analysis set included all subjects who received at least 1 dose of study intervention and have at least 1 valid blood sample drawn for PK analysis.
    End point type
    Secondary
    End point timeframe
    Days 1, 29, 85, 113, 169
    End point values
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Number of subjects analysed
    0 [17]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ±
    Notes
    [17] - This endpoint was not assessed due to premature termination of the study.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Up to 1 month 26 days
    Adverse event reporting additional description
    Safety analysis set included all subjects who received at least 1 dose of study intervention within this intervention-specific appendix (ISA). Subjects were analysed according to the study intervention they actually received.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Reporting group description
    Subject received JNJ-73763989 200 milligrams (mg) subcutaneous (SC) injection on Day 1 plus NA treatment (entecavir [ETV] 0.5 mg tablet) orally once daily from Day 1 to Day 16 plus pegylated interferon alpha-2a (PegIFN-alpha-2a) 180 micrograms (mcg) SC injection on Days 1, 8, and 15.

    Serious adverse events
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Arm 1: JNJ-73763989+nucleos(t)ide analog (NA)+PegIFN-alpha-2a
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Data could not be reported as only 1 subject was enrolled in the study who did not experience any non-serious adverse event.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    06 Oct 2021
    The primary reasons for this amendment was to include pre-specified nucleos(t)ide analog (NA) treatment completion criteria, and to add a new NA re-treatment criterion and more frequent monitoring for subjects who met the NA treatment completion criteria based on the Week 24 (or Follow-up Week 2) results and discontinued NA treatment during follow-up.
    01 Dec 2021
    The primary reason for this amendment was to update the criteria for post-treatment monitoring and for nucleos(t)ide analog (NA) re-treatment for subjects who discontinued NA treatment at Follow-up Week 2.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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