Clinical Trial Results:
A Randomized, Double-blind, Placebo-controlled Phase 2b Study to Evaluate Efficacy, Pharmacokinetics, and Safety of 48-week Study Intervention With JNJ-73763989+JNJ-56136379+Nucleos(t)ide Analog (NA) Regimen Compared to NA Alone in e Antigen-negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection
Summary
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EudraCT number |
2019-002674-31 |
Trial protocol |
BE DE FR PL ES IT |
Global end of trial date |
09 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
24 Jun 2023
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First version publication date |
24 Jun 2023
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
73763989PAHPB2002
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04129554 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Janssen Sciences Ireland Unlimited Company
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Sponsor organisation address |
Ringaskiddy, Co. Cork, Barnahely, Ireland, P43 E773
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Public contact |
Clinical Registry Group, Janssen Sciences Ireland Unlimited Company, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Sciences Ireland Unlimited Company, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Jun 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
09 Jun 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of the study was to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by hepatitis B surface antigen (HBsAg) levels.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practice and applicable regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Nov 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 9
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Country: Number of subjects enrolled |
Germany: 12
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Country: Number of subjects enrolled |
Spain: 25
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Country: Number of subjects enrolled |
France: 21
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Country: Number of subjects enrolled |
United Kingdom: 18
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Country: Number of subjects enrolled |
Italy: 22
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Country: Number of subjects enrolled |
Poland: 23
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Worldwide total number of subjects |
130
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EEA total number of subjects |
112
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
127
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||
Pre-assignment
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Screening details |
A total of 130 subjects were enrolled and randomised in the study, out of which 121 subjects completed the study. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Nucleos(t)ide analog (NA) | ||||||||||||||||||
Arm description |
Subjects received matching placebo for JNJ-73763989 by subcutaneous injection once every 4 weeks, along with matching placebo for JNJ-56136379 once daily and NA treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) once daily up to 48 weeks. | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo for JNJ-73763989
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects received matching placebo for JNJ-73763989 once every 4 weeks up to 48 weeks.
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Investigational medicinal product name |
Placebo for JNJ-56136379
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received matching placebo for JNJ-56136379 once daily up to 48 weeks
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Investigational medicinal product name |
Entecavir (ETV) monohydrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received ETV monohydrate 0.5 milligrams (mg) once daily up to 48 weeks as NA treatment.
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Investigational medicinal product name |
Tenofovir disoproxil fumarate (TDF)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received TDF 300 mg once daily up to 48 weeks as NA treatment.
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Investigational medicinal product name |
Tenofovir alafenamide (TAF)
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received TAF 25 mg once daily up to 48 weeks as NA treatment.
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Arm title
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JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA | ||||||||||||||||||
Arm description |
Subjects received JNJ-73763989 200 mg subcutaneously, once every 4 weeks, along with JNJ-56136379 250 mg tablet, once daily and NA treatment (either ETV, TDF, or TAF) once daily up to 48 weeks. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
JNJ-73763989
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects received JNJ-73763989 200 mg once every 4 weeks up to 48 weeks.
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Investigational medicinal product name |
JNJ-56136379
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received JNJ-56136379 250 mg once daily up to 48 weeks
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Investigational medicinal product name |
ETV monohydrate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received ETV 0.5 mg once daily up to 48 weeks as NA treatment.
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Investigational medicinal product name |
TDF
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received TDF 300 mg once daily up to 48 weeks as NA treatment.
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Investigational medicinal product name |
TAF
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received TAF 25 mg once daily up to 48 weeks as NA treatment.
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Baseline characteristics reporting groups
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Reporting group title |
Nucleos(t)ide analog (NA)
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Reporting group description |
Subjects received matching placebo for JNJ-73763989 by subcutaneous injection once every 4 weeks, along with matching placebo for JNJ-56136379 once daily and NA treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) once daily up to 48 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
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Reporting group description |
Subjects received JNJ-73763989 200 mg subcutaneously, once every 4 weeks, along with JNJ-56136379 250 mg tablet, once daily and NA treatment (either ETV, TDF, or TAF) once daily up to 48 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Nucleos(t)ide analog (NA)
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Reporting group description |
Subjects received matching placebo for JNJ-73763989 by subcutaneous injection once every 4 weeks, along with matching placebo for JNJ-56136379 once daily and NA treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) once daily up to 48 weeks. | ||
Reporting group title |
JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
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Reporting group description |
Subjects received JNJ-73763989 200 mg subcutaneously, once every 4 weeks, along with JNJ-56136379 250 mg tablet, once daily and NA treatment (either ETV, TDF, or TAF) once daily up to 48 weeks. |
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End point title |
Percentage of Subjects with Hepatitis B Surface Antigen (HBsAg) Seroclearance Without Restarting NA Treatment at Week 72 [1] | ||||||||||||
End point description |
Percentage of subjects with HBsAg seroclearance at week 72 (24 weeks after completion of all study interventions at Week 48) without restarting NA treatment was reported. Seroclearance at Week 72 of the treatment defined as a confirmed loss of HBsAg at Week 72. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. This outcome measure was planned to be analyzed at specified timepoint only. Modified intent-to-treat (mITT) was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this end point.
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End point type |
Primary
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End point timeframe |
Week 72
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Treatment Emergent Adverse Events (TEAEs) [2] | ||||||||||||
End point description |
An adverse event (AE) was any untoward medical occurrence in a clinical study subject who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then). Safety assessments included regular monitoring of hematology, blood chemistry, blood coagulation, urine analysis, urine chemistry, renal biomarkers; periodic measurement of vital signs and electrocardiograms (ECGs); and performance of physical examinations. Safety analysis set included all randomised subjects who received at least 1 dose of study drug. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' (number evaluable) signifies number of subjects analysed at each specified timepoints.
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End point type |
Primary
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End point timeframe |
Up to Week 102
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Treatment Emergent Serious Adverse Events (SAEs) [3] | ||||||||||||
End point description |
An AE was any untoward medical occurrence in a clinical study subject who was administered a pharmaceutical (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE was defined as the AEs occurring after first administration of study intervention (or worsened since then). SAEs included any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the off spring of a study subject. Safety analysis set included all randomised subjects who received at least 1 dose of study drug. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this end point and 'n' (number evaluable) signifies number of subjects analysed at each specified timepoints.
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End point type |
Primary
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End point timeframe |
Up to Week 102
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Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with HBsAg Seroclearance at Week 48 | ||||||||||||
End point description |
Percentage of subjects with hepatitis B surface antigen (HBsAg) seroclearance at Week 48 were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 48
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Hepatitis B virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) | ||||||||||||
End point description |
Percentage of subjects with HBV DNA <LLOQ (20 international units per millilitres [IU/mL]) at week 48 was reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 48
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment) | ||||||||||||
End point description |
Percentage of subjects with HBsAg seroclearance at Week 96 (48 weeks after stopping all study interventions at Week 48 without restarting NA treatment) was reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 96
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with (Sustained) Reduction, Suppression, and/or Seroclearance | ||||||||||||||||||
End point description |
Percentage of subjects with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen [HBsAg] and HBV DNA) off-treatment were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Up to Week 96
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with HBsAg Seroconversion at Week 96 | ||||||||||||
End point description |
HBsAg seroconversion was defined as HBsAg seroclearance together with appearance of anti-hepatitis B surface (HBs) or anti-hepatitis e (HBe) antibodies, respectively. Percentage of subjects with HBsAg seroconversion were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 96
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No statistical analyses for this end point |
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End point title |
Change from Baseline in HBsAg at Weeks 48, 72 and 96 | |||||||||||||||||||||
End point description |
Change from baseline in HBsAg was reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint and 'n' (number evaluable) signifies number of subjects analysed at each specified timepoints.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 48, 72, and 96
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No statistical analyses for this end point |
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End point title |
Change from Baseline in HBV DNA at Weeks 48, 72 and 96 | |||||||||||||||||||||
End point description |
Change from baseline in HBV DNA were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this end point.
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End point type |
Secondary
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End point timeframe |
Baseline, Weeks 48, 72, and 96
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No statistical analyses for this end point |
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End point title |
Time to Achieve First HBsAg Seroclearance | ||||||||||||
End point description |
Time to achieve first HBsAg seroclearance was defined as the number of days between the date of first study treatment intake and the date of the first occurrence of HBsAg seroclearance. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint. Here, '99999' indicated that since there were only less number of events reported therefore, the median survival time was not estimable.
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End point type |
Secondary
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End point timeframe |
Up to Week 96
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with HBsAg Levels Greater Than (>) 1 log10 IU/mL Decline From Baseline | ||||||||||||
End point description |
Percentage of subjects with HBsAg Levels >1 log10 IU/mL decline from baseline were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 96
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96 | |||||||||||||||||||||
End point description |
Percentage of subjects with HBsAg Levels <100 IU/mL at different timepoints were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this outcome measure.
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End point type |
Secondary
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End point timeframe |
Weeks 48, 72, and 96
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with HBV DNA Levels Less Than (<) LLOQ | ||||||||||||
End point description |
Percentage of Subjects with HBV DNA levels <LLOQ were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
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End point type |
Secondary
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End point timeframe |
Week 96
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects with Flares | |||||||||||||||||||||||||||||||||||||||||||||
End point description |
Percentage of subjects with flares (virologic, biochemical and clinical flares) were reported. Biochemical flare was defined as confirmed alanine transaminase flare and/or aspartate aminotransferase flare >=3*upper limit of normal and >=3*nadir. Virologic flare was defined per Derivation 1 (2 consecutive visits) HBV DNA >peak threshold in subjects who were off-treatment and had HBV DNA <LLOQ at the last observed time point on all study interventions and per Derivation 2 (2 consecutive visits) HBV DNA >peak threshold in subjects who were off-treatment and had HBVDNA >=LLOQ at the last observed time point on all study interventions. Clinical flare was defined as subjects with both virologic and biochemical flare. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
|
|||||||||||||||||||||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||||||||||||||||||||
End point timeframe |
Week 96
|
|||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects with Virologic Breakthrough | ||||||||||||
End point description |
Percentage of subjects with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by greater than (>) 1 log10 IU/mL from nadir level or confirmed on treatment level >200 IU/mL in subjects who had HBV DNA level below <LLOQ of the HBV DNA assay were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Week 48
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
End point title |
Percentage of Subjects Requiring NA Re-Treatment During Follow-up | ||||||||||||
End point description |
Percentage of subjects requiring NA re-treatment during follow-up were reported. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint.
|
||||||||||||
End point type |
Secondary
|
||||||||||||
End point timeframe |
Week 96
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
||||||||||||||||||||||||||||
End point title |
Correlation Coefficient Between On-treatment HBsAg Change from Baseline with On-treatment HBV Blood Markers and Baseline Characteristics | |||||||||||||||||||||||||||
End point description |
Correlation coefficient between on-treatment HBsAg change from baseline with on-treatment HBV blood markers and baseline characteristics were reported. HBsAg change from baseline at FU Week 24 were analysed against age, baseline NA treatment duration, HBsAg value at baseline, HBsAg change from baseline at Week 24, and HBsAg change from baseline at Week 48. Here, baseline is specified as 'bs', duration as 'du', change as 'chn' and week 'wk'. mITT was defined as all subjects who were randomized in the study and received at least one dose of study intervention excluding those subjects impacted by the pandemic. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this outcome measure.
|
|||||||||||||||||||||||||||
End point type |
Secondary
|
|||||||||||||||||||||||||||
End point timeframe |
Baseline to Week 96
|
|||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Observed Concentration at Predose (C[predose]) of JNJ-73763976 [4] | ||||||||
End point description |
C(predose) was defined as the observed concentration at predose of JNJ-73763976. Pharmacokinetic (PK) analysis set was defined as subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this endpoint. NA was tenofovir disoproxil fumarate (TDF). Here, '99999'' indicated that data was below quantification limit (<2.1 ng/mL).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Predose
|
||||||||
Notes [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Maximum Observed Analyte Concentration (Cmax) of Dose Normalized to 1 mg (Cmax[Dose Normalised]) of JNJ-73763976 [5] | ||||||||
End point description |
Cmax(Dose Normalised) was defined as the maximum observed analyte concentration of JNJ-73763976 dose normalized to 1 mg. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h (AUC[0-24h]) of JNJ-73763976 [6] | ||||||||
End point description |
AUC(0-24h) was defined as the area under the analyte concentration versus time curve from time 0 to 24 h of JNJ-73763976. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
24 hours postdose
|
||||||||
Notes [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Observed Concentration at 24 h Postdose (C[24h]) of JNJ-73763976 [7] | ||||||||
End point description |
C(24h) was defined as the observed concentration at 24 h postdose of JNJ-73763976. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
24 hours postdose
|
||||||||
Notes [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-73763976 [8] | ||||||||
End point description |
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763976. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number of subjects analysed) signifies subjects who were evaluable for this outcome measure. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 [9] | ||||||||
End point description |
Cmax was defined as the maximum concentration of JNJ-73763976. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. NA was TDF. Here, 'N' (number analysed) signifies number of subjects analysed for this end point.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h of Dose Normalized to 1 mg (AUC[0-24h], Dose Normalised) of JNJ-73763976 [10] | ||||||||
End point description |
AUC([0-24h], Dose Normalised) was defined as the area under the analyte concentration versus time curve from time 0 to 24 h of JNJ-73763976 dose normalized to 1 mg. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Observed Concentration at Predose (C[predose]) of JNJ-73763924 [11] | ||||||||
End point description |
C(predose) was defined as the observed concentration at predose of JNJ-73763924. PK analysis set was defined as subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed at each specified endpoint. NA was tenofovir disoproxil fumarate (TDF). Here, '99999'' indicates that data was below quantification limit (<2.1 ng/mL).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Predose
|
||||||||
Notes [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 [12] | ||||||||
End point description |
Cmax was defined as the maximum concentration of JNJ-73763924. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. NA was TDF. Here, 'N' (number analysed) signifies number of subjects analysed for this end point.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-73763924 [13] | ||||||||
End point description |
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763924. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sampl6e drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Observed Concentration at 24 h Postdose (C[24h]) of JNJ-73763924 [14] | ||||||||
End point description |
C(24h) was defined as the observed concentration at 24 h postdose of JNJ-73763924. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
24 hour postdose
|
||||||||
Notes [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h (AUC[0-24h]) of JNJ-73763924 [15] | ||||||||
End point description |
AUC(0-24h) was defined as the area under the analyte concentration versus time curve from time 0 to 24 h of JNJ-73763924. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
24 hour postdose
|
||||||||
Notes [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Maximum Observed Analyte Concentration (Cmax) of Dose Normalized to 1 mg (Cmax[Dose Normalised]) of JNJ-73763924 [16] | ||||||||
End point description |
Cmax(Dose Normalised) was defined as the maximum observed analyte concentration of JNJ-73763924 dose normalized to 1 mg. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379 [17] | ||||||||
End point description |
Ctau was defined as the observed or predicted concentration at the end of a dosing interval of JNJ-56136379. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Time to Reach the Maximum Observed Plasma Concentration (tmax) of JNJ-56136379 [18] | ||||||||
End point description |
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-56136379. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379 [19] | ||||||||
End point description |
Cmax was defined as the maximum concentration of JNJ-56136379. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. NA was TDF. Here, 'N' (number analysed) signifies number of subjects analysed for this end point.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Observed Concentration at Predose (C[predose]) of JNJ-56136379 [20] | ||||||||
End point description |
C(predose) was defined as the observed concentration at predose of JNJ-56136379. PK analysis set was defined as subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed at each specified end point. NA was tenofovir disoproxil fumarate (TDF).
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Predose
|
||||||||
Notes [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 h of Dose Normalized to 1 mg (AUC[0-24h], Dose Normalised) of JNJ-73763924 [21] | ||||||||
End point description |
AUC([0-24h], Dose Normalised) was defined as the area under the analyte concentration versus time curve from time 0 to 24 h of JNJ-73763924 dose normalized to 1 mg. PK analysis set included subjects who had received at least 1 dose of any of the study interventions and had at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||
End point title |
Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379 [22] | ||||||||
End point description |
AUCtau was defined as the area under the analyte concentration versus time curve during a dosing interval at steady state of JNJ-56136379. PK analysis set included subjects who have received at least 1 dose of any of the study interventions and have at least 1 valid blood sample drawn for PK analysis. Here, 'N' (number analysed) signifies number of subjects analysed for this end point. NA was TDF.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to Day 337
|
||||||||
Notes [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analysed for specified arms only. |
|||||||||
|
|||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
Up to Week 102 (including 6 weeks of screening)
|
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Adverse event reporting additional description |
The safety analysis set included all subjects who received at least 1 dose of study drug.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
|
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Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
JNJ-73763989 (200 milligrams [mg])+JNJ-56136379 (250 mg)+NA
|
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Reporting group description |
Subjects received JNJ-73763989 200 mg, subcutaneously, every 4 weeks, along with JNJ-56136379 250 mg, tablet, once daily and NA treatment (either ETV, TDF, or TAF) once daily up to 48 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Nucleos(t)ide Analog (NA)
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Reporting group description |
Subjects received matching placebo for JNJ-73763989 subcutaneously injection once every 4 weeks, with matching placebo for JNJ-56136379 once daily and NA treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF] or tenofovir alafenamide [TAF]) once daily up to 48 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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26 Sep 2019 |
The purpose of the amendment was to include the following changes: methods for handling of missing data, the exclusion criterion on allergies was broadened to also include placebo content, a reference to the prescribing information of ETV, TDF, and TAF was added, unblinding wording was updated to emphasize subject safety, and a more general recommendation to consider alternative concomitant medications or adjusted doses was provided. |
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20 Jan 2020 |
The purpose of the amendment was to include the following main changes: additional information for the management of hematologic abnormalities was provided and the preclinical section was updated to include the preliminary results from the 3-month combination toxicity study with JNJ-3989 and JNJ-6379. |
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30 Sep 2021 |
The purpose of the amendment was to include an additional NA re-treatment criterion as an urgent safety measure, after the report of a severe hepatitis B reactivation requiring liver transplantation following NA treatment discontinuation in a subject in the control arm. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |