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)
NCT ID: NCT06963710
Last Updated: 2026-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-07-15
2028-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALG-000184
Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.
ALG-000184
300 mg tablet
TDF
Orally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.
TDF
300 mg tablet
Interventions
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ALG-000184
300 mg tablet
TDF
300 mg tablet
Eligibility Criteria
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Inclusion Criteria
2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
3. HBsAg ≥LLOQ.
4. HBV DNA ≥20,000 IU/mL.
5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
6. Must have the following chronic hepatitis B virus infection treatment status at screening:
1. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM \[i.e., Treatment Naïve (TN) subjects\], OR
2. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects).
Exclusion Criteria
2. Positive for anti-HBs antibodies.
3. History or current evidence of cirrhosis.
4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
5. History of, or current evidence of, hepatic decompensation.
6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
7. Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug
8. Exclusionary screening laboratory values include:
1. Aspartate aminotransferase (AST) \>8×ULN,
2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
3. International Normalization Ratio (INR) \>1.2×ULN
18 Years
65 Years
ALL
No
Sponsors
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Aligos Therapeutics
INDUSTRY
Responsible Party
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Locations
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Aligos Investigational Site
Chandler, Arizona, United States
Aligos Investigational Site
Coronado, California, United States
Aligos Investigational Site
Garden Grove, California, United States
Aligos Investigational Site
Los Angeles, California, United States
Aligos Investigational Site
Palo Alto, California, United States
Aligos Investigational Site
Pasadena, California, United States
Aligos Investigational Site
Rialto, California, United States
Aligos Investigational Site
San Francisco, California, United States
Aligos Investigational Site
San Jose, California, United States
Aligos Investigational Site
Miami, Florida, United States
Aligos Investigational Site
Miami, Florida, United States
Aligos Investigational Site
Marrero, Louisiana, United States
Aligos Investigational Site
Baltimore, Maryland, United States
Aligos Investigational Site
Chevy Chase, Maryland, United States
Aligos Investigational Site
Boston, Massachusetts, United States
Aligos Investigational Site
Manhasset, New York, United States
Aligos Investigational Site
New York, New York, United States
Aligos Investigational Site
Durham, North Carolina, United States
Aligos Investigational Site
Sliven, , Bulgaria
Aligos Investigational Sites
Sofia, , Bulgaria
Aligos Investigational Site
Stara Zagora, , Bulgaria
Aligos Investigational Site
Edmonton, , Canada
Aligos Investigational Site
Ottawa, , Canada
Aligos Investigational Site
Toronto, , Canada
Aligos Investigational Sites
Vancouver, , Canada
Aligos Investigational Sites
Beijing, , China
Aligos Investigational Site
Chengdu, , China
Aligos Investigational Site
Chongqing, , China
Aligos Investigational Sites
Guangzhou, , China
Aligos Investigational Site
Nanjing, , China
Aligos Investigational Sites
Shanghai, , China
Aligos Investigational Site
Clichy, , France
Aligos Investigational Site
Limoges, , France
Aligos Investigational Site
Nice, , France
Aligos Investigational Site
Rennes, , France
Aligos Investigational Site
Rouen, , France
Aligos Investigational Site
Toulouse, , France
Aligos Investigational Sites
Hong Kong, , Hong Kong
Aligos Investigational Site
Milan, , Italy
Aligos Investigational Site
Chisinau, , Moldova
Aligos Investigational Site
Auckland, , New Zealand
Aligos Investigational Sites
Bucharest, , Romania
Aligos Investigational Site
Ansan, , South Korea
Aligos Investigational Site
Busan, , South Korea
Aligos Investigational Sites
Seoul, , South Korea
Aligos Investigational Site
Ulsan, , South Korea
Aligos Investigational Site
Yangsan, , South Korea
Aligos Investigational Site
Barcelona, , Spain
Aligos Investigational Site
Pontevedra, , Spain
Aligos Investigational Site
Chiayi City, , Taiwan
Aligos Investigational Site
Kaohsiung City, , Taiwan
Aligos Investigational Site
Taichung, , Taiwan
Aligos Investigational Site
Tainan, , Taiwan
Aligos Investigational Site
Taipei, , Taiwan
Aligos Investigational Site
Glasgow, , United Kingdom
Aligos Investigational Site
Leicester, , United Kingdom
Aligos Investigational Sites
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ALG-000184-202
Identifier Type: -
Identifier Source: org_study_id
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