A Study of ABI-H2158-containing Regimens in Participants With Chronic Hepatitis B Virus Infection
NCT ID: NCT04398134
Last Updated: 2022-09-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
88 participants
INTERVENTIONAL
2020-08-28
2021-12-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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ABI-H2158 plus ETV
ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
ABI-H2158
3 X 100 mg tablets for oral administration
Entecavir (ETV)
0.5 mg tablet for oral administration
Placebo plus ETV
Placebo matching ABI-2158 300 mg tablet once daily for 72 weeks plus ETV 0.5 mg tablet once daily for 96 weeks
Placebo
Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV)
0.5 mg tablet for oral administration
Interventions
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ABI-H2158
3 X 100 mg tablets for oral administration
Placebo
Sugar pill manufactured to mimic the ABI-H2158 tablets
Entecavir (ETV)
0.5 mg tablet for oral administration
Eligibility Criteria
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Inclusion Criteria
* HBeAg ≥500 IU/mL at Screening
* In good general health except for chronic HBV infection for ≥6 months documented, for example, by at least two measurements of HBsAg positivity and/or detectable HBV DNA ≥6 months apart
* Lack of cirrhosis or advanced liver disease
Exclusion Criteria
* History or evidence of advanced liver disease or hepatic decompensation (including jaundice, ascites, portal hypertension, gastrointestinal bleeding, esophageal varices, hepatic encephalopathy)
* History or presence of clinically significant medical conditions requiring frequent medical management or pharmacologic or surgical treatment
18 Years
65 Years
ALL
No
Sponsors
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Assembly Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Grace Wang
Role: STUDY_DIRECTOR
Assembly Biosciences
Locations
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Coalition of Inclusive Medicine
Los Angeles, California, United States
California Liver Research Institute
Pasadena, California, United States
Stanford University Medical Center
Redwood City, California, United States
Research and Education Inc.
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Miami/Schiff Center for Liver Diseases
Miami, Florida, United States
Johns Hopkins University
Baltimore, Maryland, United States
New Discovery, LLC
Flushing, New York, United States
Northwell Health Center for Liver Disease
Manhasset, New York, United States
NYU Langone Health
New York, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
University of Washington
Seattle, Washington, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
John Hunter Hospital
New Lambton, New South Wales, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
St. Vincent's Hospital
Fitzroy, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Melbourne Health
Parkville, Victoria, Australia
(G.I.R.I.) GI Research Institute
Vancouver, British Columbia, Canada
Toronto Liver Centre
Toronto, Ontario, Canada
The First Hospital of Jilin University
Changchun, Jilin, China
The Second Affliated Hospital of Chongqing Medical University
Chongqing, Yuzhong District, China
Xiangya Hospital Central South University
Changsha, , China
Nanfang Hospital
Guangzhou, , China
Guangzhou Eighth People's Hospital - Guangzhou Infectious Diseases Hospital
Guangzhou, , China
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Queen Mary Hospital
Hong Kong, , Hong Kong
Auckland Clinical Studies
Auckland, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Pusan National University Hospital
Busan, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Kaohsiung Medical University Hospital
Kaohsiung City, Sanmin District, Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital Taipei Branch
Taipei, , Taiwan
Chang Gung Memorial Hospital (CGMH) - Linkou Branch
Taoyuan District, , Taiwan
King's College Hospital
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-004902-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ABI-H2158-201
Identifier Type: -
Identifier Source: org_study_id
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