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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: JNJ-56136379; Drug: JNJ-73763989; Drug: Nucleos(t)ide Analog (NA); Drug: Placebo for JNJ-56136379; Drug: Placebo for JNJ-73763989

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.

• Study Type: Interventional
• Enrollment (Actual): 471
• Phase: Phase 2

Contacts and Locations

Study Locations

• Belgium
  • Brussel, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Edegem, Belgium, 2650
    • UZA-SGS
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • UZ Leuven
• Brazil
  • Manaus, Brazil, 69040-000
    • Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT
  • Salvador, Brazil, 40110-060
    • Universidade Federal da Bahia - Hospital Professor Edgard Santos
  • Sao Paulo, Brazil, 05403-000
    • Hospital das Clínicas da Faculdade de Medicina da USP
• Canada
  • Toronto, Canada, ON M5G 2C4
    • Toronto General Hospital
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • University of Calgary
    • Edmonton, Alberta, Canada, T6G 2G3
      • University of Alberta - Faculty of Medicine & Dentistry
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • GI Research Institute (G.I.R.I.)
    • Vancouver, British Columbia, Canada, V6Z2C7
      • Vancouver ID Research and Care Centre Society
• China
  • Guangzhou, China, 510515
    • Nanfang Hospital
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • FN Hradec Kralove
  • Plzen, Czechia, 32600
    • Research Site s.r.o.
  • Praha, Czechia, 140 21
    • IKEM
  • Praha 2, Czechia, 120 00
    • KLIN MED s.r.o
• France
  • Clichy, France, 92110
    • Hopital Beaujon
  • Grenoble, France, 38043
    • CHU de Grenoble - Hôpital Albert Michallon
  • Lyon, France, 69004
    • Hopital de la Croix Rousse
  • Marseille, France, 13008
    • Hôpital Saint Joseph
  • Nantes, France, 44093
    • CHU de Nantes hotel-Dieu
  • Paris, France, 75012
    • Hopital Saint-Antoine
  • Rennes, France, 35033
    • CHU Rennes - Hôpital Pontchaillou
  • Villejuif, France, 94800
    • Hopital Paul Brousse
• Germany
  • Berlin, Germany, 10787
    • EPIMED GmbH
  • Essen, Germany, 45147
    • Universitätsklinikum Essen
  • Frankfurt, Germany, 60590
    • Universitätsklinikum Johann Wolfgang Goethe- Universität Frankfurt Medizinische Klinik 1
  • 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
    • Universitätsklinikum Leipzig
  • Mainz, Germany, 55121
    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
• Hong Kong
  • Hong Kong, Hong Kong
    • The University of Hong Kong
  • Shatin, Hong Kong
    • The Chinese University of Hong Kong
• 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
• Japan
  • Bunkyo-Ku, Japan, 113-8519
    • Tokyo Medical and Dental University Hospital
  • Chiba, Japan, 260-8677
    • Chiba University Hospital
  • Fukui City, Japan, 918-8503
    • Fukui-ken Saiseikai Hospital
  • Fukuyama, Japan, 721-8511
    • Fukuyama City Hospital
  • Hiroshima-shi, Japan, 734-8551
    • Hiroshima University Hospital
  • Kagawa, Japan, 760-8557
    • Kagawa Prefectural Central Hospital
  • Kashihara, Japan, 634-8522
    • Nara Medical University Hospital
  • Musashino, Japan, 180-8610
    • Musashino Red Cross Hospital
  • Nagasaki, Japan, 856-8562
    • National Hospital Organization Nagasaki Medical Center
  • Nagoya, Japan, 467-8602
    • Nagoya City University Hospital
  • Nishinomiya, Japan, 663-8501
    • The Hospital of Hyogo College of Medicine
  • Sapporo-shi, Japan, 060-8648
    • Hokkaido University Hospital
  • Suita-shi, Japan, 565-0871
    • Osaka University Hospital
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital
  • Toyoake, Japan, 470-1192
    • Fujita Health University Hospital
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
• Malaysia
  • Alor Setar, Malaysia, 05460
    • Hospital Sultanah Bahiyah
  • Batu Caves, Malaysia, 68100
    • Hospital Selayang
  • Kota Bharu, Malaysia, 16150
    • Hospital University Sains Malaysia
  • Kuala Lumpur, Malaysia, 59100
    • University Malaya Medical Centre
• 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
  • Warszawa, Poland, 01-201
    • Wojewodzki Szpital Zakazny w Warszawie
  • Wroclaw, Poland, 50-136
    • SP ZOZ Wroclawskie Centrum Zdrowia
• Russian Federation
  • Chelyabinsk, Russian Federation, 454092
    • Ural State Medical University
  • Ekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital #1
  • Krasnoyarsk, Russian Federation, 660049
    • Krasnoyarsk Regional Center For AIDS And Infectious Diseases Treatment And Prophylaxis
  • Moscow, Russian Federation, 121170
    • Clinic of the Modern Medicine
  • Novosibirsk, Russian Federation, 630005
    • Medical Center SibNovoMed LLC
  • Saint Petersburg, Russian Federation, 190103
    • St. Petersburg City Center for AIDS and Infectious Diseases Treatment and Prophylaxis
  • Saint Petersburg, Russian Federation, 196645
    • Republican Clinical Infectious Hospital
  • Saint-Petersburg, Russian Federation, 195067
    • Clinical Infectious Diseases Hospital n. a. S.P. Botkin
  • Samara, Russian Federation, 443063
    • Medical Company Hepatolog Ltd
  • Smolensk, Russian Federation, 214018
    • Smolensk Regional Clinical Hospital
  • Stavropol, Russian Federation, 355017
    • Stavropol State Medical University
• Spain
  • Barcelona, Spain, 8035
    • Hosp. Univ. Vall D Hebron
  • Barcelona, Spain, 08028
    • Hosp. Clinic I Provincial de Barcelona
  • Madrid, Spain, 28041
    • Hosp. Univ. 12 de Octubre
  • Madrid, Spain, 28222
    • Hospital Puerta de Hierro
  • Santander, Spain, 39008
    • Hosp. Univ. Marques de Valdecilla
  • Valencia, Spain, 46014
    • Hosp. Gral. Univ. Valencia
• Thailand
  • Bangkok, Thailand, 10700
    • Siriraj Hospital
  • Bangkok, Thailand, 10500
    • King Chulalongkorn Memorial Hospital
  • Chiang Mai, Thailand, 50200
    • Chiang Mai University Hospital
  • Songkla, Thailand, 90110
    • Prince of Songkla University
• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe University Hospital
  • Ankara, Turkey, 06620
    • Ankara University Medical Faculty
  • Ankara, Turkey, 6800
    • Ankara Sehir Hastanesi
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Izmir, Turkey, 35100
    • Ege University Medical of Faculty, Department of Gastroenterology
  • Trabzon, Turkey, 61080
    • Karadeniz Teknik University Medical Faculty
• United Kingdom
  • Glasgow, United Kingdom, G12 0YN
    • NHS Greater Glasgow and Clyde - Gartnavel General Hospital
  • London, United Kingdom, E1 1BB
    • Grahame Hayton Unit
  • London, United Kingdom, SE5 9RF
    • Kings College Hospital
  • London, United Kingdom, SW17 0RE
    • St George's, University of London and St George's University Hospitals NHS Foundation Trust
• United States
  • California
    • Bakersfield, California, United States, 93301
      • The Office of Franco Felizarta, MD
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group Inc
    • San Clemente, California, United States, 92673
      • Southern California GI and Liver Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Hillsborough, New Jersey, United States, 08844
      • I.D. Care, Inc.
  • New York
    • New York, New York, United States, 10016
      • NYU Hepatology Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 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 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: JNJ-73763989 (medium dose) + JNJ-56136379 + NA; 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.	Drug: JNJ-56136379; JNJ-56136379 tablets will be administered orally.; Drug: JNJ-73763989; JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.; Drug: Nucleos(t)ide Analog (NA); NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.
Experimental: Arm 2: JNJ-73763989 (high dose) + Placebo + NA; 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.	Drug: JNJ-73763989; JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.; Drug: Nucleos(t)ide Analog (NA); NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.; Drug: Placebo for JNJ-56136379; Placebo for JNJ-56136379 tablets will be administered orally.
Experimental: Arm 3: JNJ-73763989 (medium dose) + Placebo + NA; 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.	Drug: JNJ-73763989; JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.; Drug: Nucleos(t)ide Analog (NA); NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.; Drug: Placebo for JNJ-56136379; Placebo for JNJ-56136379 tablets will be administered orally.
Experimental: Arm 4: JNJ-73763989 (low dose) + Placebo + NA; 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.	Drug: JNJ-73763989; JNJ-73763989 will be administered as medium dose (Arms 1 and 3), high dose (Arm 2), and low dose (Arm 4) as subcutaneous injection.; Drug: Nucleos(t)ide Analog (NA); NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.; Drug: Placebo for JNJ-56136379; Placebo for JNJ-56136379 tablets will be administered orally.
Experimental: Arm 5: Placebo + JNJ-56136379 + NA; 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.	Drug: JNJ-56136379; JNJ-56136379 tablets will be administered orally.; Drug: Nucleos(t)ide Analog (NA); NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.; Drug: Placebo for JNJ-73763989; Placebo for JNJ-73763989 will be administered as subcutaneous injection.
Placebo Comparator: Arm 6 (Control): Placebo + Placebo + NA; Participants will receive placebo for JNJ-73763989 and placebo for JNJ-56136379 along with NA (either ETV, TDF, or TAF) up to 48 weeks.	Drug: Nucleos(t)ide Analog (NA); NA treatment that is either of ETV, TDF or TAF tablets will be administered orally.; Drug: Placebo for JNJ-56136379; Placebo for JNJ-56136379 tablets will be administered orally.; Drug: Placebo for JNJ-73763989; Placebo for JNJ-73763989 will be administered as subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to follow-up (maximum up to 150 weeks)
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.	Up to follow-up (maximum up to 150 weeks)
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.	Week 72 and Week 96
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.	Week 72 and Week 96
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.	Up to 96 weeks
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.	Up to 150 weeks
Percentage of Participants Requiring NA Re-treatment During Follow-up	Percentage of participants requiring NA re-treatment during follow-up will be reported.	Up to 150 weeks
Percentage of Participants with Relapse	Percentage of participants with relapse will be reported.	Up to 150 weeks
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.	Up to Week 96
Percentage of Participants with HBsAg Seroconversion	Percentage of participants with HBsAg seroconversion will be reported.	Up to 150 weeks
Percentage of Participants with HBeAg Seroconversion	Percentage of participants with HBeAg seroconversion will be reported.	Up to 150 weeks
Change From Baseline in HBsAg Levels	Change from baseline in HBsAg levels will be determined.	Baseline up to follow up (up to Week 150)
Change From Baseline in HBeAg Levels	Change from baseline in HBeAg levels will be determined.	Baseline up to follow up (up to Week 150)
Change from Baseline in HBV DNA Levels	Change from baseline in HBV DNA levels will be determined.	Baseline up to follow up (up to Week 150)
Time to Achieve HBsAg Seroclearance	Time to achieve HBsAg seroclearance will be determined.	Up to Week 96
Time to Achieve HBeAg Seroclearance	Time to achieve HBeAg seroclearance will be determined.	Up to Week 96
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.	Baseline up to Week 150
Percentage of HBeAg-positive Participants with HBeAg Levels	Percentage of HBeAg-positive participants with HBeAg levels will be reported.	Baseline up to Week 150
Percentage of Participants with ALT Decrease and Normalization	Percentage of participants with alanine aminotransferase (ALT) decrease and normalization will be reported.	Up to follow-up (maximum up to 150 weeks)
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.	Up to Week 48
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.	Up to 150 weeks
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.	Days 1, 29, 85, 169 and 337
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.	Days 1, 29, 85, 169 and 337
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.	Days 1, 29, 85, 169 and 337

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): August 1, 2019
• Primary Completion (Actual): March 29, 2021
• Study Completion (Actual): April 26, 2022

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Virus Diseases; Hepatitis B, Chronic; Herpesviridae Infections; Anti-Infective Agents; Antiviral Agents; JNJ-56136379
• Other Study ID Numbers: CR108608; 2019-000622-22 (EudraCT Number); 73763989HPB2001 (Other Identifier: Janssen Sciences Ireland UC)

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