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: 2025-11-06
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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Keywords
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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 ≥100 IU/mL.
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
Pasadena, California, United States
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Rialto, California, United States
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San Francisco, California, United States
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San Jose, California, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Marrero, Louisiana, United States
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Baltimore, Maryland, United States
Aligos Investigational Site
Chevy Chase, Maryland, United States
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Manhasset, New York, United States
Aligos Investigational Site
New York, New York, United States
Aligos Investigational Site
Ottawa, , Canada
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Toronto, , Canada
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Vancouver, , Canada
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Beijing, , 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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Hong Kong, , Hong Kong
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Chisinau, , Moldova
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Auckland, , New Zealand
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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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Chiayi City, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
Aligos Investigational Site
Tainan City, , 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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Aligos Investigational Site
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Aligos Investigational Sites
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Other Identifiers
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ALG-000184-202
Identifier Type: -
Identifier Source: org_study_id