A Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME)
Start Date
7/15/2025
Completion Date
8/1/2028
Summary
This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.
Detailed Description
This is a randomized, double-blind, active-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of 48 weeks of oral (PO) once daily (QD) monotherapy with ALG-000184 versus TDF in treatment naive (TN) or currently not treated (CNT) HBeAg-positive and HBeAg-negative subjects with chronic HBV infection (inclusive of chronic infection and/or chronic hepatitis). A total of approximately 200 eligible subjects will be enrolled across 2 study parts. Part 1 will be an evaluation of HBeAg-positive subjects with chronic HBV infection and Part 2 will be an evaluation of HBeAg-negative subjects with chronic HBV infection. Each study part will consist of a main study and an exploratory liver biopsy sub-study. Following the 48-week double-blind dosing period (Week 48), all participating subjects (in Parts 1 and 2) will be allowed to roll over into a 48 week (i.e., Week 48-96) open-label treatment extension period where they will all receive ALG-000184 monotherapy.
Eligibility Criteria
Age Range: 18 years to 65 years
Interventions
ALG-000184
TDF
Conditions
Locations
Aligos Investigational Site
Chandler, Arizona 85224
United States
Aligos Investigational Site
Coronado, California 92118
United States
Aligos Investigational Site
Garden Grove, California 92840
United States
Aligos Investigational Site
Los Angeles, California 90033
United States
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Palo Alto, California 94304
United States
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Pasadena, California 91105
United States
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Rialto, California 92377
United States
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San Francisco, California 94117
United States
Aligos Investigational Site
San Jose, California 95116
United States
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Miami, Florida 33136
United States
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Miami, Florida 33173
United States
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Marrero, Louisiana 70072
United States
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Baltimore, Maryland 21287
United States
Aligos Investigational Site
Chevy Chase, Maryland 20815
United States
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Boston, Massachusetts 02114
United States
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Manhasset, New York 10075
United States
Aligos Investigational Site
New York, New York 10016
United States
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Durham, North Carolina 27710
United States
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Sliven,
Bulgaria
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Sofia,
Bulgaria
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Stara Zagora,
Bulgaria
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Edmonton,
Canada
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Ottawa,
Canada
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Toronto,
Canada
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Vancouver,
Canada
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Beijing,
China
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Changchun,
China
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Chengdu,
China
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Chongqing,
China
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Guangzhou,
China
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Nanjing,
China
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Shanghai,
China
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Clichy,
France
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Limoges,
France
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Nice,
France
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Rennes,
France
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Rouen,
France
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Toulouse,
France
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Hong Kong,
Hong Kong
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Milan,
Italy
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Chisinau,
Moldova
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Auckland,
New Zealand
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Bucharest,
Romania
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Ansan,
South Korea
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Busan,
South Korea
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Seoul,
South Korea
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Ulsan,
South Korea
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Yangsan,
South Korea
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Barcelona,
Spain
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Pontevedra,
Spain
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Chiayi City,
Taiwan
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Kaohsiung City,
Taiwan
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Taichung,
Taiwan
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Tainan,
Taiwan
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Taipei,
Taiwan
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Glasgow,
United Kingdom
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Leicester,
United Kingdom
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London,
United Kingdom