Last updated on March 2019

An Efficacy Safety and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection

Brief description of study

The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.

Detailed Study Description

The main study consists of 2-parts and each part will consist of 2 types of Chronic Hepatitis B-infected participant populations. Each part of the study will consist of screening phase (up to 8 weeks), treatment phase (24 weeks or 48 weeks, depending on treatment response), and post-treatment follow-up phase (24 weeks or 48 weeks, depending on treatment response). The duration of individual participation will be up to approximately 56 weeks (participants not eligible to continue treatment in extension phase), up to 80 weeks (participants continuing treatment in extension phase but not meeting treatment completion criteria), or up to 104 weeks (participants meeting treatment completion criteria). The safety and efficacy will be monitored throughout the study. In a separate substudy, at selected clinical sites, percutaneous core liver biopsy will be performed to evaluate changes of intrahepatic viral parameters.

Clinical Study Identifier: NCT03361956

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Scripps Clinic

La Jolla, CA United States
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Orlando Immunology Center

Orlando, FL United States
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Tulane Medical Center (TMC)

New Orleans, LA United States
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I.D. Care, Inc.

Hillsborough, NJ United States
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UPMC Center For Liver Diseases

Pittsburgh, PA United States
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UZ Antwerpen

Edegem, Belgium
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Asan Medical Center

Seoul, Korea, Republic of
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ID Clinic

Myslowice, Poland
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Medical Center 'Zdorovaya Semya' LLC

Novosibirsk, Russian Federation
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Institute of Human Virology

Baltimore, MD United States
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Medical Center 'SibNovoMed' LLC

Novosibirsk, Russian Federation
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NYU Hepatology Associates

New York, NY United States
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Recruitment Status: Open

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