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A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection (REEF-1)

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-73763989
Placebo for JNJ-73763989
JNJ-56136379
Placebo for JNJ-56136379
Nucleos(t)ide Analog (NA)
Sponsored by
Janssen Sciences Ireland UC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening
  • Body mass index (BMI) between 18.0 and 35.0 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
  • 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
  • Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 and JNJ 6379 or their excipients or excipients of the 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
  • Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
  • Male participants who plan to father a child while enrolled
  • Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
  • Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)

Sites / Locations

  • The Office of Franco Felizarta, MD
  • Ruane Clinical Research Group Inc
  • Southern California GI and Liver Center
  • Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
  • Johns Hopkins University
  • Washington University School of Medicine
  • I.D. Care, Inc.
  • NYU Hepatology Associates
  • Cliniques Universitaires Saint-Luc
  • UZ Antwerpen
  • UZA-SGS
  • Universitair Ziekenhuis Gent
  • UZ Leuven
  • Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT
  • Universidade Federal da Bahia - Hospital Professor Edgard Santos
  • Hospital Das Clinicas Da Faculdade De Medicina Da USP
  • University of Calgary
  • University of Alberta - Faculty of Medicine & Dentistry
  • GI Research Institute (G.I.R.I.)
  • Vancouver ID Research and Care Centre Society
  • Toronto General Hospital
  • Nanfang Hospital
  • FN Hradec Kralove
  • RESEARCH SITE s.r.o.
  • KLIN MED s.r.o
  • IKEM
  • Hopital Beaujon
  • CHU de Grenoble - Hopital Albert Michallon
  • Hopital de La Croix Rousse
  • Hopital Saint Joseph
  • CHU de Nantes hôtel-Dieu
  • Hopital Saint-Antoine
  • Chu Rennes - Hopital Pontchaillou
  • Hopital Paul Brousse
  • EPIMED GmbH
  • Universitatsklinikum Essen
  • Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
  • ICH Study Center GmbH & Co. KG
  • University Medical Center
  • Medizinische Hochschule Hannover
  • Universitatsklinikum Leipzig
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • The University of Hong Kong
  • The Chinese University of Hong Kong
  • Azienda Ospedaliera Universitaria Policlinico G. Martino
  • Irccs Ospedale Maggiore Di Milano
  • Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara
  • Azienda Ospedaliero Universitaria Pisana
  • Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
  • Tokyo Medical and Dental University Hospital
  • Chiba University Hospital
  • Fukui-ken Saiseikai Hospital
  • Fukuyama City Hospital
  • Hiroshima University Hospital
  • Kagawa Prefectural Central Hospital
  • Nara Medical University Hospital
  • Musashino Red Cross Hospital
  • National Hospital Organization Nagasaki Medical Center
  • Nagoya City University Hospital
  • The Hospital of Hyogo College of Medicine
  • Hokkaido University Hospital
  • Osaka University Hospital
  • Toranomon Hospital
  • Fujita Health University Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • Samsung Medical Center
  • Hospital Sultanah Bahiyah
  • Hospital Selayang
  • Hospital University Sains Malaysia
  • University Malaya Medical Centre
  • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
  • Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
  • ID Clinic
  • Wojewodzki Szpital Zakazny w Warszawie
  • SP ZOZ Wroclawskie Centrum Zdrowia
  • Ural State Medical University
  • Sverdlovsk Regional Clinical Hospital #1
  • Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
  • Clinic of the Modern Medicine
  • Medical Center SibNovoMed LLC
  • St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
  • Republican Clinical Infectious Hospital
  • Clinical Infectious Diseases Hospital n. a. S.P. Botkin
  • Medical Company Hepatolog Ltd
  • Smolensk Regional Clinical Hospital
  • Stavropol State Medical University
  • Hosp. Clinic I Provincial de Barcelona
  • Hosp. Univ. Vall D Hebron
  • Hosp. Univ. 12 de Octubre
  • Hospital Puerta De Hierro
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Gral. Univ. Valencia
  • King Chulalongkorn Memorial Hospital
  • Siriraj Hospital
  • Chiang Mai University Hospital
  • Prince Of Songkla University
  • Hacettepe University Hospital
  • Ankara University Medical Faculty
  • Ankara Sehir Hastanesi
  • Istanbul University Cerrahpasa Medical Faculty
  • Ege University Medical of Faculty, Department of Gastroenterology
  • Karadeniz Teknik University Medical Faculty
  • NHS Greater Glasgow and Clyde - Gartnavel General Hospital
  • Grahame Hayton Unit
  • Kings College Hospital
  • St George's, University of London and St George's University Hospitals NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NA

Arm 2: JNJ-73763989 (high dose) + Placebo + NA

Arm 3: JNJ-73763989 (medium dose) + Placebo + NA

Arm 4: JNJ-73763989 (low dose) + Placebo + NA

Arm 5: Placebo + JNJ-56136379 + NA

Arm 6 (Control): Placebo + Placebo + NA

Arm Description

Participants will receive medium dose of JNJ-73763989 along with JNJ-56136379 and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide [TAF]) up to 48 weeks.

Participants will receive high dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.

Participants will receive medium dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.

Participants will receive low dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.

Participants will receive placebo for JNJ-73763989 and a fixed dose of JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.

Participants will receive placebo for JNJ-73763989 and placebo for JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Meeting the Nucleos(t)ide Analog (NA) Treatment Completion Criteria at Week 48
Percentage of participants meeting the NA treatment completion criteria at week 48 will be reported.

Secondary Outcome Measures

Number of Participants with Adverse Events (AE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants with Abnormalities in Clinical Laboratory Tests, 12-Lead Electrocardiogram (ECG), and Vital Signs
Number of participants with abnormalities in clinical laboratory tests, 12-lead ECG, and vital signs will be reported.
Percentage of Participants with HBsAg Seroclearance After Completion of all Study Intervention
Percentage of participants with hepatitis B surface antigen (HBsAg) seroclearance after completion of all study intervention will be reported.
Percentage of Participants with HBV DNA less than (<) Lower Limit of Quantification (LLOQ) After Completion of all Study Intervention
Percentage participants with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) <LLOQ after completion of all study intervention will be reported.
Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up
Percentage of participants meeting the NA treatment completion criteria during follow-up will be reported.
Percentage of Participants with HBsAg Seroclearance After Completion of NA Treatment at any Time During Follow-up
Percentage of participants with HBsAg seroclearance after completion of NA treatment at any time during follow-up will be reported.
Percentage of Participants Requiring NA Re-treatment During Follow-up
Percentage of participants requiring NA re-treatment during follow-up will be reported.
Percentage of Participants with Relapse
Percentage of participants with relapse will be reported.
Percentage of Participants with (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Markers
Percentage of participants with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen [HBsAg], hepatitis B e antigen [HBeAg], HBV DNA and alanine aminotransferase [ALT]) will be reported.
Percentage of Participants with HBsAg Seroconversion
Percentage of participants with HBsAg seroconversion will be reported.
Percentage of Participants with HBeAg Seroconversion
Percentage of participants with HBeAg seroconversion will be reported.
Change From Baseline in HBsAg Levels
Change from baseline in HBsAg levels will be determined.
Change From Baseline in HBeAg Levels
Change from baseline in HBeAg levels will be determined.
Change from Baseline in HBV DNA Levels
Change from baseline in HBV DNA levels will be determined.
Time to Achieve HBsAg Seroclearance
Time to achieve HBsAg seroclearance will be determined.
Time to Achieve HBeAg Seroclearance
Time to achieve HBeAg seroclearance will be determined.
Percentage of Participants with <100 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline
Percentage of participants with less than (<) 100 international units per milliliter (IU/mL) or greater than (>) 1 log10 IU/mL reduction in HBsAg from baseline will be assessed.
Percentage of HBeAg-positive Participants with HBeAg Levels
Percentage of HBeAg-positive participants with HBeAg levels will be reported.
Percentage of Participants with ALT Decrease and Normalization
Percentage of participants with alanine aminotransferase (ALT) decrease and normalization will be reported.
Percentage of Participants with Virologic Breakthrough
Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by >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 will be reported.
Percentage of Participants with Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up
Percentage of participants who reach HBV DNA undetectability after re-start of NA treatment during follow-up will be reported.
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-73763989
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-56136379
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of NA
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.

Full Information

First Posted
June 10, 2019
Last Updated
May 5, 2023
Sponsor
Janssen Sciences Ireland UC
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1. Study Identification

Unique Protocol Identification Number
NCT03982186
Brief Title
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
Acronym
REEF-1
Official Title
A Phase 2b, Multicenter, Double-blind, Active-controlled, Randomized Study to Investigate the Efficacy and Safety of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
March 29, 2021 (Actual)
Study Completion Date
April 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Sciences Ireland UC

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA (with and without JNJ-56136379) and of JNJ-56136379+NA.
Detailed Description
Hepatitis B virus (HBV) is a small deoxyribonucleic acid virus that specifically infects the human liver. The acute phase of infection is either followed by an immune controlled state or progresses to chronic hepatitis B. The worldwide estimated prevalence of chronic HBV infection is about 292 million people affected. Hepatitis B surface antigen (HBsAg) seroclearance is currently considered to be associated with the most thorough suppression of HBV replication (termed functional cure). With current available NA treatment strategies, rate of HBsAg seroclearance remains very low (around 3 percent [%]) even under long-term treatment. Also, with the persistently high global prevalence of HBV-associated mortality, there is a medical need for more effective finite treatment options that lead to sustained HBsAg seroclearance. JNJ-73763989 is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic HBV infection via ribonucleic acid interference mechanism. JNJ-56136379 is an orally administered capsid assembly modulator that is being developed for the treatment of chronic HBV infection. The aim of the study is to evaluate efficacy as measured by proportion of participants who completed 48-week study intervention and qualified for stopping NA treatment at Week 48. The study includes: Screening phase (4 weeks), Double-blind study intervention phase (from Day 1 up to Week 48), and Follow-up phase (48 weeks after end of investigational intervention with a maximum duration of 96 weeks). The duration of individual study participation will be between 100 and 150 weeks. Safety and tolerability (including adverse events [AEs] and Serious AEs, laboratory assessments, electrocardiogram [ECG], vital signs, physical examination), efficacy (including HBsAg seroclearance), and pharmacokinetics will be assessed throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
471 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NA
Arm Type
Experimental
Arm Description
Participants will receive medium dose of JNJ-73763989 along with JNJ-56136379 and nucleos(t)ide analog (NA) treatment (either entecavir [ETV], tenofovir disoproxil fumarate [TDF], or tenofovir alafenamide [TAF]) up to 48 weeks.
Arm Title
Arm 2: JNJ-73763989 (high dose) + Placebo + NA
Arm Type
Experimental
Arm Description
Participants will receive high dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Arm Title
Arm 3: JNJ-73763989 (medium dose) + Placebo + NA
Arm Type
Experimental
Arm Description
Participants will receive medium dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Arm Title
Arm 4: JNJ-73763989 (low dose) + Placebo + NA
Arm Type
Experimental
Arm Description
Participants will receive low dose of JNJ-73763989 along with placebo for JNJ-56136379 and NA (either ETV, TDF, or TAF) up to 48 weeks.
Arm Title
Arm 5: Placebo + JNJ-56136379 + NA
Arm Type
Experimental
Arm Description
Participants will receive placebo for JNJ-73763989 and a fixed dose of JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Arm Title
Arm 6 (Control): Placebo + Placebo + NA
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for JNJ-73763989 and placebo for JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.
Intervention Type
Drug
Intervention Name(s)
JNJ-73763989
Intervention Description
JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Placebo for JNJ-73763989
Intervention Description
Placebo for JNJ-73763989 will be administered as subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
JNJ-56136379
Intervention Description
JNJ-56136379 tablets will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo for JNJ-56136379
Intervention Description
Placebo for JNJ-56136379 tablets will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Nucleos(t)ide Analog (NA)
Intervention Description
NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.
Primary Outcome Measure Information:
Title
Percentage of Participants Meeting the Nucleos(t)ide Analog (NA) Treatment Completion Criteria at Week 48
Description
Percentage of participants meeting the NA treatment completion criteria at week 48 will be reported.
Time Frame
Week 48
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events (AE) and Serious Adverse Events (SAE) as a Measure of Safety and Tolerability
Description
An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
Up to follow-up (maximum up to 150 weeks)
Title
Number of Participants with Abnormalities in Clinical Laboratory Tests, 12-Lead Electrocardiogram (ECG), and Vital Signs
Description
Number of participants with abnormalities in clinical laboratory tests, 12-lead ECG, and vital signs will be reported.
Time Frame
Up to follow-up (maximum up to 150 weeks)
Title
Percentage of Participants with HBsAg Seroclearance After Completion of all Study Intervention
Description
Percentage of participants with hepatitis B surface antigen (HBsAg) seroclearance after completion of all study intervention will be reported.
Time Frame
Week 72 and Week 96
Title
Percentage of Participants with HBV DNA less than (<) Lower Limit of Quantification (LLOQ) After Completion of all Study Intervention
Description
Percentage participants with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) <LLOQ after completion of all study intervention will be reported.
Time Frame
Week 72 and Week 96
Title
Percentage of Participants Meeting the NA Treatment Completion Criteria During Follow-up
Description
Percentage of participants meeting the NA treatment completion criteria during follow-up will be reported.
Time Frame
Up to 96 weeks
Title
Percentage of Participants with HBsAg Seroclearance After Completion of NA Treatment at any Time During Follow-up
Description
Percentage of participants with HBsAg seroclearance after completion of NA treatment at any time during follow-up will be reported.
Time Frame
Up to 150 weeks
Title
Percentage of Participants Requiring NA Re-treatment During Follow-up
Description
Percentage of participants requiring NA re-treatment during follow-up will be reported.
Time Frame
Up to 150 weeks
Title
Percentage of Participants with Relapse
Description
Percentage of participants with relapse will be reported.
Time Frame
Up to 150 weeks
Title
Percentage of Participants with (Sustained) Reduction, Suppression, and/or Seroclearance Considering Single and Multiple Markers
Description
Percentage of participants with (sustained) reduction, suppression, and/or seroclearance considering single and multiple markers (such as hepatitis B surface antigen [HBsAg], hepatitis B e antigen [HBeAg], HBV DNA and alanine aminotransferase [ALT]) will be reported.
Time Frame
Up to Week 96
Title
Percentage of Participants with HBsAg Seroconversion
Description
Percentage of participants with HBsAg seroconversion will be reported.
Time Frame
Up to 150 weeks
Title
Percentage of Participants with HBeAg Seroconversion
Description
Percentage of participants with HBeAg seroconversion will be reported.
Time Frame
Up to 150 weeks
Title
Change From Baseline in HBsAg Levels
Description
Change from baseline in HBsAg levels will be determined.
Time Frame
Baseline up to follow up (up to Week 150)
Title
Change From Baseline in HBeAg Levels
Description
Change from baseline in HBeAg levels will be determined.
Time Frame
Baseline up to follow up (up to Week 150)
Title
Change from Baseline in HBV DNA Levels
Description
Change from baseline in HBV DNA levels will be determined.
Time Frame
Baseline up to follow up (up to Week 150)
Title
Time to Achieve HBsAg Seroclearance
Description
Time to achieve HBsAg seroclearance will be determined.
Time Frame
Up to Week 96
Title
Time to Achieve HBeAg Seroclearance
Description
Time to achieve HBeAg seroclearance will be determined.
Time Frame
Up to Week 96
Title
Percentage of Participants with <100 IU/mL or >1 log10 IU/mL Reduction in HBsAg From Baseline
Description
Percentage of participants with less than (<) 100 international units per milliliter (IU/mL) or greater than (>) 1 log10 IU/mL reduction in HBsAg from baseline will be assessed.
Time Frame
Baseline up to Week 150
Title
Percentage of HBeAg-positive Participants with HBeAg Levels
Description
Percentage of HBeAg-positive participants with HBeAg levels will be reported.
Time Frame
Baseline up to Week 150
Title
Percentage of Participants with ALT Decrease and Normalization
Description
Percentage of participants with alanine aminotransferase (ALT) decrease and normalization will be reported.
Time Frame
Up to follow-up (maximum up to 150 weeks)
Title
Percentage of Participants with Virologic Breakthrough
Description
Percentage of participants with virologic breakthrough defined as confirmed on-treatment HBV DNA increase by >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 will be reported.
Time Frame
Up to Week 48
Title
Percentage of Participants with Undetectable HBV DNA Levels After Re-start of NA Treatment During Follow-up
Description
Percentage of participants who reach HBV DNA undetectability after re-start of NA treatment during follow-up will be reported.
Time Frame
Up to 150 weeks
Title
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-73763989
Description
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Time Frame
Days 1, 29, 85, 169 and 337
Title
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of JNJ-56136379
Description
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Time Frame
Days 1, 29, 85, 169 and 337
Title
Area Under the Plasma Concentration-time Curve over the Dosing Interval (tau) at Steady-state (AUCtau,ss) of NA
Description
The AUC (tau,ss) is the area under the plasma concentration time curve observed during a dosing interval (tau) at steady state.
Time Frame
Days 1, 29, 85, 169 and 337

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 surface antigen (HBsAg) greater than (>) 100 International Units per Milliliter (IU/mL) at screening Body mass index (BMI) between 18.0 and 35.0 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 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 Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 and JNJ 6379 or their excipients or excipients of the 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 Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention Male participants who plan to father a child while enrolled Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Sciences Ireland UC Clinical Trial
Organizational Affiliation
Janssen Sciences Ireland UC
Official's Role
Study Director
Facility Information:
Facility Name
The Office of Franco Felizarta, MD
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Ruane Clinical Research Group Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Southern California GI and Liver Center
City
San Clemente
State/Province
California
ZIP/Postal Code
92673
Country
United States
Facility Name
Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20016
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
I.D. Care, Inc.
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
NYU Hepatology Associates
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZA-SGS
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT
City
Manaus
ZIP/Postal Code
69040-000
Country
Brazil
Facility Name
Universidade Federal da Bahia - Hospital Professor Edgard Santos
City
Salvador
ZIP/Postal Code
40110-060
Country
Brazil
Facility Name
Hospital Das Clinicas Da Faculdade De Medicina Da USP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
University of Alberta - Faculty of Medicine & Dentistry
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Facility Name
GI Research Institute (G.I.R.I.)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Vancouver ID Research and Care Centre Society
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z2C7
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
ZIP/Postal Code
ON M5G 2C4
Country
Canada
Facility Name
Nanfang Hospital
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
FN Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
RESEARCH SITE s.r.o.
City
Plzen
ZIP/Postal Code
32600
Country
Czechia
Facility Name
KLIN MED s.r.o
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
IKEM
City
Praha
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHU de Grenoble - Hopital Albert Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital de La Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
CHU de Nantes hôtel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Chu Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Paul Brousse
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
EPIMED GmbH
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
ICH Study Center GmbH & Co. KG
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
University Medical Center
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitatsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55121
Country
Germany
Facility Name
The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Facility Name
The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong
Facility Name
Azienda Ospedaliera Universitaria Policlinico G. Martino
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Irccs Ospedale Maggiore Di Milano
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara
City
Modena
ZIP/Postal Code
41126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
City
Rome
ZIP/Postal Code
00161
Country
Italy
Facility Name
Tokyo Medical and Dental University Hospital
City
Bunkyo-Ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Chiba University Hospital
City
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Fukui-ken Saiseikai Hospital
City
Fukui City
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Fukuyama City Hospital
City
Fukuyama
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima-shi
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Kagawa
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Musashino Red Cross Hospital
City
Musashino
ZIP/Postal Code
180-8610
Country
Japan
Facility Name
National Hospital Organization Nagasaki Medical Center
City
Nagasaki
ZIP/Postal Code
856-8562
Country
Japan
Facility Name
Nagoya City University Hospital
City
Nagoya
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
The Hospital of Hyogo College of Medicine
City
Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Hokkaido University Hospital
City
Sapporo-shi
ZIP/Postal Code
060-8648
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
Fujita Health University Hospital
City
Toyoake
ZIP/Postal Code
470-1192
Country
Japan
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Hospital Sultanah Bahiyah
City
Alor Setar
ZIP/Postal Code
05460
Country
Malaysia
Facility Name
Hospital Selayang
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Facility Name
Hospital University Sains Malaysia
City
Kota Bharu
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Facility Name
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-030
Country
Poland
Facility Name
Neutrum Lekarze M.Hlebowicz i Partnerzy spolka partnerska
City
Gdansk
ZIP/Postal Code
80-462
Country
Poland
Facility Name
ID Clinic
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Wojewodzki Szpital Zakazny w Warszawie
City
Warszawa
ZIP/Postal Code
01-201
Country
Poland
Facility Name
SP ZOZ Wroclawskie Centrum Zdrowia
City
Wroclaw
ZIP/Postal Code
50-136
Country
Poland
Facility Name
Ural State Medical University
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Facility Name
Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
City
Krasnoyarsk
ZIP/Postal Code
660049
Country
Russian Federation
Facility Name
Clinic of the Modern Medicine
City
Moscow
ZIP/Postal Code
121170
Country
Russian Federation
Facility Name
Medical Center SibNovoMed LLC
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
City
Saint Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
Republican Clinical Infectious Hospital
City
Saint Petersburg
ZIP/Postal Code
196645
Country
Russian Federation
Facility Name
Clinical Infectious Diseases Hospital n. a. S.P. Botkin
City
Saint-Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
Medical Company Hepatolog Ltd
City
Samara
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Stavropol State Medical University
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Puerta De Hierro
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Gral. Univ. Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
ZIP/Postal Code
10500
Country
Thailand
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Chiang Mai University Hospital
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Prince Of Songkla University
City
Songkla
ZIP/Postal Code
90110
Country
Thailand
Facility Name
Hacettepe University Hospital
City
Ankara
ZIP/Postal Code
06230
Country
Turkey
Facility Name
Ankara University Medical Faculty
City
Ankara
ZIP/Postal Code
06620
Country
Turkey
Facility Name
Ankara Sehir Hastanesi
City
Ankara
ZIP/Postal Code
6800
Country
Turkey
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Ege University Medical of Faculty, Department of Gastroenterology
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Karadeniz Teknik University Medical Faculty
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
NHS Greater Glasgow and Clyde - Gartnavel General Hospital
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Grahame Hayton Unit
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RF
Country
United Kingdom
Facility Name
St George's, University of London and St George's University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection

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