Last updated on January 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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The Office of Franco Felizarta, MD
Bakersfield, CA United States
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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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Rush University Medical Center
Chicago, IL 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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SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg)
Antwerpen, Belgium
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Cliniques Universitaires Saint-Luc
Bruxelles, Belgium
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UZ Antwerpen
Edegem, Belgium
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University of Calgary
Calgary, AB Canada
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Vancouver ID Research and Care Centre Society
Vancouver, BC Canada
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GI Research Institute (G.I.R.I.)
Vancouver, BC Canada
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McGill University Health Centre
Montreal, QC Canada
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Toronto General Hospital
Toronto, Canada
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Peking University People's Hospital
Beijing, China
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The First Hospital of Jilin University
Changchun, China
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Nanfang Hospital
Guangzhou, China
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Ruijin Hospital, Shanghai Jiao Tong University
Shanghai, China
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H pital Beaujon
Clichy, France
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Hopital de La Croix Rousse
Lyon, France
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Hopital Saint-Antoine
Paris, France
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Hopital Paul Brousse
Villejuif, France
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Zentrum f r Infektiologie Berlin Prenzlauer Berg GmbH
Berlin, Germany
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Universitatsklinikum Essen
Essen, Germany
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Universit tsklinikum Johann Wolfgang Goethe- Universit t Frankfurt Medizinische Klinik 1
Frankfurt, Germany
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Asklepios Klinik St. Georg, Haus Lifi - Studien und Projekte GmbH
Hamburg, Germany
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St. Josefs-Hospital Wiesbaden
Wiesbaden, Germany
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Humanity & Healthy Medical Centre
Hong Kong, Hong Kong
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The University of Hong Kong
Hong Kong, Hong Kong
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The Chinese University of Hong Kong
Shatin, Hong Kong
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Irccs Ospedale Maggiore Di Milano
Milano, Italy
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ASST Grande Ospedale Metropolitano Niguarda
Milano, Italy
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Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
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Hiroshima University Hospital
Hiroshima, Japan
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Musashino Red Cross Hospital
Musashino, Japan
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NHO Nagasaki Medical Center
Nagasaki, Japan
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Nagoya City University Hospital
Nagoya, Japan
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Osaka University Hospital
Osaka, Japan
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Pusan National University Hospital
Busan, Korea, Republic of
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Seoul National University Hospital
Seoul, Korea, Republic of
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Severance Hospital, Yonsei University Health System
Seoul, Korea, Republic of
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Asan Medical Center
Seoul, Korea, Republic of
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Hospital Sultanah Bahiyah
Alor Setar, Malaysia
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University Malaya Medical Centre
Kuala Lumpur, Malaysia
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Szpital Specjalistyczny w Chorzowie
Chorzow, Poland
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Wojewodzki Szpital Zespolony
Kielce, Poland
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ID Clinic
Myslowice, Poland
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SP ZOZ Wroclawskie Centrum Zdrowia
Wroclaw, Poland
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Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg, Russian Federation
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Medical Center 'Zdorovaya Semya' LLC
Novosibirsk, Russian Federation
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Medical Company 'Hepatolog' Ltd
Samara, Russian Federation
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Stavropol State Medical University
Stavropol, Russian Federation
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Hosp. Clinic I Provincial de Barcelona
Barcelona, Spain
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Hosp. Univ. Vall D Hebron
Barcelona, Spain
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Hosp. Univ. Ramon Y Cajal
Madrid, Spain
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Hosp. Univ. Marques de Valdecilla
Santander, Spain
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Hosp. Virgen Del Rocio
Sevilla, Spain
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Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
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Taichung Veterans General Hospital
Taichung, Taiwan
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National Cheng Kung University Hospital
Tainan, Taiwan
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Chang Gung Memorial Hospital Linkou Branch
Tao-Yuan, Taiwan
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Institute of Human Virology
Baltimore, MD United States
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Beiijing Friendship Hospital, Capital Medical University
Beijing, China
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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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King Chulalongkorn Memorial Hospital
Bangkok, Thailand
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Siriraj Hospital
Bangkok, Thailand
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Chiang Mai University Hospital
Chiang Mai, Thailand
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Prince Of Songkla University
Songkla, Thailand
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Recruitment Status: Open


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