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Clinical Trials in the UK / NCT06963710
Active, not recruiting Phase 2

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)

NCT06963710 · tracked via the Priya Life Science UK tracker
Sponsor
Aligos Therapeutics
Phase
Phase 2
Started
2025-07-15
Last updated
2026-09-11

Condition(s) studied

Chronic Hepatitis B Infection

Investigational drug(s) / intervention(s)

ALG-000184TDF

ALG-000184: 300 mg tablet

TDF: 300 mg tablet

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria: 1. Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2 (or minimun age by local regulatory requirements). 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). Key Exclusion Criteria: 1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology. 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

Primary outcome measure(s)

Trial sites (41)

FacilityCityRegionStatus
Aligos Investigational Site Coronado California
Aligos Investigational Site Pasadena California
Aligos Investigational Site Rialto California
Aligos Investigational Site San Francisco California
Aligos Investigational Site San Jose California
Aligos Investigational Site Miami Florida
Aligos Investigational Sites Sofia 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 Changchun 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 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 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

+ 1 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06963710 on ClinicalTrials.gov ↗ ← All trials in the UK