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

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: Completed
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: JNJ-56136379; Drug: Tenofovir alafenamide (TAF); Drug: JNJ-73763989; Drug: Entecavir (ETV) monohydrate; Drug: Tenofovir disoproxil fumarate (TDF); Drug: Placebo for JNJ-73763989; Drug: Placebo for JNJ-56136379

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: Interventional
• Enrollment (Actual): 130
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Hepatitis B Surface Antigen (HBsAg) Seroclearance at Week 72 Without Restarting NA Treatment	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

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	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)	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	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	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)	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	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	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	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	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 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	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	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)	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	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	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	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	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)	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)	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)	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)	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)	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])	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)	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)	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)	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)	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)	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)	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])	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)	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	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	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	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	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	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

• Sponsor: Janssen Sciences Ireland UC
• Investigators: Study Director: Janssen Sciences Ireland UC Clinical Trial, Janssen Sciences Ireland UC

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2019
• Primary Completion (Actual): July 8, 2021
• Study Completion (Actual): June 9, 2022

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 17, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis A; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Virus Diseases; Herpesviridae Infections; Anti-Infective Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Nucleic Acid Synthesis Inhibitors; Antiviral Agents; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; JNJ-56136379; Entecavir
• Other Study ID 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