A Study of 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

January 31, 2025 updated by: Janssen Sciences Ireland UC

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

The purpose of this study is 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 HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Hepatitis B virus (HBV) is a small deoxyribonucleic acid (DNA) virus that infects the liver and can cause either acute or chronic infection. It consists of a so-called nucleocapsid in which viral DNA is packed with hepatitis B core protein (HBc) and membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic HBV infection may lead to serious illnesses like cirrhosis and hepatocellular carcinoma (HCC). Oral treatment with NAs is effective at suppressing viral DNA formation and lowering virus concentration in blood to levels below lower limit of quantification (LLOQ). JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism but rarely lead to functional cure defined as sustained loss of HBs Ag and HBV DNA in serum. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for treatment of chronic HBV infection. The aim of study is to evaluate efficacy of 48-week study intervention with JNJ-3989+JNJ-6379+NA regimen compared to NA alone, assessed by HBsAg seroclearance at Week 72 (i.e., 24 weeks after completion of all study interventions at Week 48) without restarting NA treatment in HBeAg negative virologically suppressed chronic hepatitis B (CHB) infected participants who received NA treatment for at least 2 years prior to screening. The study will be 2.3 years and will be conducted in 3 phases: a screening phase (4 weeks), a study intervention phase (48 weeks), and a follow-up phase (48 weeks). Safety will be evaluated by AEs including AEs of special interest to any of the study interventions, clinical laboratory tests, ECGs, vital signs, and physical examinations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint Luc
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Edegem, Belgium, 2650
        • SGS Belgium NV
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • UZ Leuven
  • France
      • Clichy, France, 92110
        • Hôpital Beaujon
      • Lyon, France, 69004
        • Hopital de la croix rousse
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Paris, France, 75014
        • Hopital Cochin
      • Rennes, France, 35033
        • Chu Rennes Hopital Pontchaillou
      • Vandoeuvre les Nancy, France, 54511
        • CHU Nancy Brabois
      • Villejuif, France, 94800
        • Hopital Paul Brousse
  • Germany
      • Essen, Germany, 45147
        • Universitätsklinikum Essen
      • Frankfurt, Germany, 60590
        • Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Hamburg, Germany, 20146
        • ICH Study Center GmbH & Co. KG
      • Hamburg, Germany, D-20246
        • University Medical Center
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, 04103
        • Universitaetsklinikum Leipzig
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg Universität Mainz
  • Italy
      • Messina, Italy, 98124
        • Azienda Ospedaliera Universitaria Policlinico G. Martino
      • Milano, Italy, 20122
        • Irccs Ospedale Maggiore Di Milano
      • Modena, Italy, 41126
        • Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara
      • Pisa, Italy, 56124
        • Azienda Ospedaliero Universitaria Pisana
      • Rome, Italy, 00161
        • Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
  • Poland
      • Bydgoszcz, Poland, 85-030
        • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
      • Gdansk, Poland, 80-462
        • Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
      • Myslowice, Poland, 41-400
        • ID Clinic
      • Wroclaw, Poland, 50-136
        • SP ZOZ Wroclawskie Centrum Zdrowia
  • Spain
      • Barcelona, Spain, 8028
        • Hosp Clinic de Barcelona
      • Barcelona, Spain, 8035
        • Hosp Univ Vall D Hebron
      • Madrid, Spain, 28041
        • Hosp. Univ. 12 de Octubre
      • Madrid, Spain, 28222
        • Hosp. Univ. Pta. de Hierro Majadahonda
      • Santander, Spain, 39008
        • Hosp. Univ. Marques de Valdecilla
      • Valencia, Spain, 46014
        • Hosp. Gral. Univ. Valencia
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital
      • Crumpsall, United Kingdom, M8 5RB
        • North Manchester General Hospital
      • Glasgow, United Kingdom, G31 2ER
        • Glasgow Royal Infirmary
      • London, United Kingdom, E1 1BB
        • Grahame Hayton Unit
      • London, United Kingdom, SE5 9RF
        • Kings College Hospital
      • London, United Kingdom, SW17 0RE
        • St Georges University of London and St George's University Hospitals NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
  • Chronic hepatitis B virus (HBV) infection with documentation at least 6 months prior to screening
  • Hepatitis B e (antigen) (HBeAg)-negative on stable nucleotide analogue (NA) treatment for at least 24 months prior to screening
  • Hepatitis B surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening
  • Body mass index (BMI) between 18.0 and 35 kilogram per meter square (kg/m^2), extremes included
  • Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
  • Liver fibrosis stage 0-2 (Metavir) or Fibroscan less than (<) 9 Kilopascal (kPa) at screening

Exclusion Criteria:

  • Evidence of infection with hepatitis A, C, D or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
  • History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
  • Evidence of liver disease of non-HBV etiology
  • History or signs of cirrhosis or portal hypertension (nodules, no smooth liver contour, no normal portal vein, spleen size ≥12 cm) or signs of hepatocellular carcinoma (HCC)
  • Significant laboratory abnormalities as defined in the protocol at screening
  • Participants with a history of malignancy within 5 years before screening
  • Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
  • History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
  • Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
  • History of or current clinically significant skin disease or drug rash
  • Known allergies, hypersensitivity, or intolerance to JNJ-73763989 and JNJ-56136379 or their excipients or to placebo content
  • Contraindications to the use of entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF) per local prescribing information
  • Participants who have taken any therapies disallowed per protocol

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: JNJ-73763989+ JNJ-56136379+ NA
Participants will receive fixed dose of JNJ-73763989 subcutaneous injection once every 4 weeks along with fixed dose of JNJ-56136379 tablet once daily and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide [TAF]) once daily up to 48 weeks.
Drug: JNJ-56136379
JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
Drug: Tenofovir alafenamide (TAF)
TAF will be administered orally once daily up to 48 weeks as NA treatment.
Drug: JNJ-73763989
JNJ-73763989 injection will be administered subcutaneously once every 4 weeks up to 48 weeks.
Drug: Entecavir (ETV) monohydrate
ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
Drug: Tenofovir disoproxil fumarate (TDF)
TDF will be administered orally once daily up to 48 weeks as NA treatment.
Placebo Comparator: Placebo for JNJ-73763989+ Placebo for JNJ-56136379+ NA
Participants will receive matching placebo for JNJ-73763989 subcutaneous injection once every 4 weeks with matching placebo for JNJ-56136379 once daily and NA treatment (either ETV, TDF or TAF) once daily up to 48 weeks.
Drug: Tenofovir alafenamide (TAF)
TAF will be administered orally once daily up to 48 weeks as NA treatment.
Drug: Entecavir (ETV) monohydrate
ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
Drug: Tenofovir disoproxil fumarate (TDF)
TDF will be administered orally once daily up to 48 weeks as NA treatment.
Drug: Placebo for JNJ-73763989
Matching placebo for JNJ-73763989 will be administered as subcutaneous injection up to 48 weeks.
Drug: Placebo for JNJ-56136379
Matching placebo for JNJ-56136379 tablets will be administered orally up to 48 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment
Time Frame: Week 72
Percentage of participants 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.
Week 72

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From screening up to Week 102
An adverse event (AE) was any untoward medical occurrence in a clinical study participant 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).
From screening up to Week 102
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time Frame: From screening up to 102 weeks
An AE was any untoward medical occurrence in a clinical study participant 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 participant.
From screening up to 102 weeks
Percentage of Participants With HBsAg Seroclearance at Week 48
Time Frame: Week 48
Percentage of participants with hepatitis B surface antigen (HBsAg) seroclearance at Week 48 was reported. Seroclearance at Week 48 of the treatment defined as a confirmed loss of HBsAg at Week 48. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result.
Week 48
Percentage of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Less Than (<) Lower Limit of Quantification (LLOQ) at Week 48
Time Frame: Week 48
Percentage of participants with HBV DNA <LLOQ (20 international units per milliliters [IU/mL]) at Week 48 was reported.
Week 48
Percentage of Participants With HBsAg Seroclearance at Week 96 (48 Weeks After Stopping All Study Interventions at Week 48 Without Restarting NA Treatment)
Time Frame: Week 96
Percentage of participants with HBsAg seroclearance at Week 96 (48 weeks after stopping all study interventions at Week 48 without restarting NA treatment) was reported. Seroclearance at Week 96 of the treatment defined as a confirmed loss of HBsAg at Week 96. Loss is defined as a baseline HBsAg with a repeat reactive, confirmed or positive result and a post-baseline assessment with a negative result. Missing values were imputed by last observation carried forward (LOCF).
Week 96
Percentage of Participants With (Sustained) Reduction, Suppression, and/or Seroclearance
Time Frame: Baseline (Day 1) up to Week 96
Percentage of participants with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen [HBsAg] and HBV DNA) (HBsAg >= lower limit of quantification [LLOQ] and HBV DNA<2000 IU/mL; HBsAg >= LLOQ and LLOQ <= HBV DNA < 2000 IU/mL) off-treatment was reported.
Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Seroconversion at Week 96
Time Frame: Week 96
Percentage of participants with HBsAg seroconversion were reported. HBsAg seroconversion was defined as HBsAg seroclearance together with appearance of anti-hepatitis B surface (HBs) or anti-hepatitis e (HBe) antibodies, respectively.
Week 96
Change From Baseline in HBsAg Values at Weeks 48, 72, and 96
Time Frame: Baseline (Day 1), Weeks 48, 72, and 96
Change from baseline in HBsAg values was reported.
Baseline (Day 1), Weeks 48, 72, and 96
Change From Baseline in HBV DNA Values at Weeks 48, 72, and 96
Time Frame: Baseline (Day 1), Weeks 48, 72, and 96
Change from baseline in HBV DNA values was reported. Participants were considered as virologically suppressed if they were on stable HBV treatment (receiving NA treatment [ETV, TDF, or TAF)] for at least 24 months prior to screening and were on the same dose of NA treatment regimen for at least 3 months at the time of screening, and had serum HBV DNA less than (<)60 IU/mL on 2 sequential measurements at least 6 months and had documented alanine aminotransferase values <2.0* upper limit of normal on 2 sequential measurements at least 6 months apart.
Baseline (Day 1), Weeks 48, 72, and 96
Time to Achieve First HBsAg Seroclearance
Time Frame: Baseline (Day 1) up to Week 96
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.
Baseline (Day 1) up to Week 96
Percentage of Participants With Reduction of More Than (>) 1 log10 IU/mL in HBsAg Levels From Baseline
Time Frame: Baseline (Day 1) up to Week 96
Percentage of participants with reduction of >1 log10 in HBsAg Levels IU/mL from baseline was reported.
Baseline (Day 1) up to Week 96
Percentage of Participants With HBsAg Levels Less Than (<) 100 IU/mL at Weeks 48, 72, and 96
Time Frame: Weeks 48, 72, and 96
Percentage of participants with HBsAg Levels <100 IU/mL at Weeks 48, 72, and 96 was reported.
Weeks 48, 72, and 96
Percentage of Participants With HBV DNA Levels Less Than (<) LLOQ From Baseline up to Week 96 (End of Study)
Time Frame: Baseline (Day 1) up to Week 96
Percentage of Participants with HBV DNA levels <LLOQ (20 IU/mL) was reported.
Baseline (Day 1) up to Week 96
Percentage of Participants With Flares
Time Frame: Baseline (Day 1) up to Week 96
Percentage of participants with flares (virologic, biochemical and clinical flares) was reported. Biochemical flare was defined as confirmed alanine transaminase flare and/or aspartate aminotransferase flare >=3*upper limit of normal and >=3*nadir. The start of a confirmed virologic flare was defined as the first date of two consecutive visits with HBV DNA >200 IU/mL. The end date of the same confirmed virologic flare was defined as the first date when HBV DNA value returns to less than or equal to (<=)200 IU/mL or the date of NA treatment restart, whichever comes first. Clinical flare was defined as participants with both virologic and biochemical flare.
Baseline (Day 1) up to Week 96
Percentage of Participants With Virologic Breakthrough
Time Frame: Baseline (Day 1) up to Week 48
Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by more than (>) 1 log10 IU/mL from nadir level or confirmed on treatment level >200 IU/mL in participants who had HBV DNA level below <LLOQ of the HBV DNA assay was reported.
Baseline (Day 1) up to Week 48
Percentage of Participants Requiring NA Re-Treatment During Follow-up
Time Frame: Baseline (Day 1) up to Week 96
Percentage of participants requiring NA re-treatment (either ETV, TDF, or TAF) during follow-up was reported.
Baseline (Day 1) up to Week 96
Correlation Coefficient Between On-treatment HBsAg Change From Baseline With On-treatment HBV Blood Markers and Baseline Characteristics
Time Frame: Baseline (Day 1) to Week 96
Correlation coefficient between on-treatment HBsAg change from baseline with on-treatment HBV blood markers and baseline characteristics was reported at different timepoints (against age, baseline NA treatment duration, HBsAg value at baseline, HBsAg values at Weeks 24 and 48).
Baseline (Day 1) to Week 96
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763976 (Molecule of JNJ-73763989)
Time Frame: Predose at Weeks 4, 8, 12, and 16
C(predose) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989)
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Cmax was defined as the maximum observed concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763976 (Molecule of JNJ-73763989)
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763976 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763976 (Molecule of JNJ-73763989)
Time Frame: 24 hours postdose at Weeks 4, 8, 12, and 16
C(24h) was defined as the observed plasma concentration of JNJ-73763976 (a molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
24 hours postdose at Weeks 4, 8, 12, and 16
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours (AUC[0-24h]) of JNJ-73763976 (Molecule of JNJ-73763989)
Time Frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
AUC(0-24h) was defined as the area under the concentration of JNJ-73763976 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Cmax(Dose Normalized) was defined as the maximum observed concentration of JNJ-73763976 (a molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763976 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)
Time Frame: 0 to 24 hours post-dose at Weeks 4, 8, 12, and 16
AUC([0-24h], Dose Normalized) was defined as the area under the concentration of JNJ-73763976 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
0 to 24 hours post-dose at Weeks 4, 8, 12, and 16
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-73763924 (Molecule of JNJ-73763989)
Time Frame: Predose at Weeks 4, 8, 12, and 16
C(predose) was defined as the observed plasma concentration of JNJ-73763924 (a molecule of JNJ-73763989) at predose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989)
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Cmax was defined as the maximum concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-73763924 (Molecule of JNJ-73763989)
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989). PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed Plasma Concentration at 24 Hour Postdose (C[24h]) of JNJ-73763924 (Molecule of JNJ-73763989)
Time Frame: 24 hours postdose at Weeks 4, 8, 12, and 16
C(24h) was defined as the observed plasma concentration of JNJ-73763924 (molecule of JNJ-73763989) at 24 h postdose of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
24 hours postdose at Weeks 4, 8, 12, and 16
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hour (AUC[0-24h]) of JNJ-73763924 (Molecule of JNJ-73763989)
Time Frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
AUC(0-24h) was defined as the area under the concentration of JNJ-73763924 (molecule of JNJ-73763989) versus time curve from time 0 to 24 hour of JNJ-73763989. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (Cmax[Dose Normalized])
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Cmax(Dose Normalized) was defined as the maximum observed analyte concentration of JNJ-73763924 (molecule of JNJ-73763989) dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve From Time 0 to 24 Hours of JNJ-73763924 (Molecule of JNJ-73763989) Dose Normalized to 1 mg (AUC[0-24h], Dose Normalized)
Time Frame: 0 to 24 hours postdose at Weeks 4, 8, 12, and 16
AUC([0-24h], Dose Normalized) was defined as the area under the analyte concentration JNJ-73763924 (a molecule of JNJ-73763989) versus time curve from time 0 to 24 hours of JNJ-73763989 dose normalized to 1 mg. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
0 to 24 hours postdose at Weeks 4, 8, 12, and 16
Observed Plasma Concentration at Predose (C[Predose]) of JNJ-56136379
Time Frame: Predose at Weeks 4, 8, 12, and 16
C(predose) was defined as the observed plasma concentration at predose of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Predose at Weeks 4, 8, 12, and 16
Maximum Observed Analyte Concentration (Cmax) of JNJ-56136379
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Cmax was defined as the maximum observed concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of JNJ-56136379
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
tmax was defined as the time to reach the maximum observed plasma concentration of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Observed or Predicted Concentration at the End of a Dosing Interval (Ctau) of JNJ-56136379
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Ctau was defined as the observed or predicted concentration at the end of a dosing interval of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
Area Under the Analyte Concentration Versus Time Curve During a Dosing Interval at Steady State (AUCtau) of JNJ-56136379
Time Frame: Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose
AUCtau was defined as the area under the analyte concentration versus time curve during a dosing interval at steady state of JNJ-56136379. PK sample collection was done based on the availability of the participants at Weeks 4, 8, 12, or 16 and thus collected data were averaged and reported in this outcome measure.
Weeks 4, 8, 12, and 16: at Predose, 15 minutes, 30 minutes, 1, 2, 3, 4, 6, 8, 10, and 24 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Sciences Ireland UC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Sciences Ireland UC Clinical Trial, Janssen Sciences Ireland UC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108679
  • 73763989PAHPB2002 (Other Identifier: Janssen Sciences Ireland UC)
  • 2019-002674-31 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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