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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT03982186

Run by

Janssen Sciences Ireland UC

People needed

471

Starts

2019-08-01

Expected to finish

2022-04-26

Last updated by the study team

2025-02-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Ruane Clinical Research Group Inc — Los Angeles, California, United States
• Southern California GI and Liver Center — San Clemente, California, United States
• Johns Hopkins Office of Capital Region Research - Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Washington University School Of Medicine — St Louis, Missouri, United States
• I.D. Care, Inc. — Hillsborough, New Jersey, United States
• NYU Hepatology Associates — New York, New York, United States
• Cliniques Universitaires Saint Luc — Brussels, Belgium
• UZ Antwerpen — Edegem, Belgium
• UZA-SGS — Edegem, Belgium
• Universitair Ziekenhuis Gent — Ghent, Belgium
• UZ Leuven — Leuven, Belgium
• Fundacao de Medicina Tropical Doutor Heitor Vieira Dourado - FMT — Manaus, Brazil
• Universidade Federal da Bahia - Hospital Professor Edgard Santos — Salvador, Brazil
• Hospital Das Clinicas Da Faculdade De Medicina Da USP — São Paulo, Brazil
• University of Calgary — Calgary, Alberta, Canada
• University of Alberta - Faculty of Medicine & Dentistry — Edmonton, Alberta, Canada
• GI Research Institute (G.I.R.I.) — Vancouver, British Columbia, Canada
• Vancouver ID Research and Care Centre Society — Vancouver, British Columbia, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Nanfang Hospital — Guangzhou, China
• FN Hradec Kralove — Hradec Králové, Czechia
• RESEARCH SITE s.r.o. — Pilsen, Czechia
• KLIN MED s.r.o — Prague, Czechia
• The Office of Franco Felizarta, MD — Bakersfield, California, United States

Full record on ClinicalTrials.gov

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