Phase 2 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)
Key facts
- Where
- Clichy, Limoges Cedex 1, Nice, Rennes, Rouen és Toulouse Cedex 9, FranciaországSee the 6 sites
- Phase
- 2. fázis
Where in Franciaország
- Hopital BeaujonClichy, FranciaországTaking people
- Centre Hospitalier Et Universitaire De LimogesLimoges Cedex 1, FranciaországTaking people
- Centre Hospitalier Universitaire de NiceNice, FranciaországTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranciaországTaking people
- Centre Hospitalier Universitaire RouenRouen, FranciaországTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aligos Therapeutics Inc.
- Trial code
- EU 2025-521178-33-00
- Record updated
- 2026. június 12.
- Original description
To assess and compare monotherapy with ALG-000184 versus TDF in HBeAg-positive (Part 1) and HBeAg-negative (Part 2) subjects as measured by plasma HBV DNA levels.Read full original descriptionShow less
A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 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 Virus Infection (B-SUPREME)
To assess and compare monotherapy with ALG-000184 versus TDF in HBeAg-positive (Part 1) and HBeAg-negative (Part 2) subjects as measured by plasma HBV DNA levels.
Inclusion: Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2; HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2); HBsAg ≥ LLOQ; HBV DNA ≥20,000 IU/mL; A history of a clinical diagnosis of chronic HBV infection AND a serum ALT values of ≤8×ULN during screening; Must have the following chronic hepatitis B virus infection treatment status at screening: a. 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 b. 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: Positive for anti-HBs antibodies; 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; Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology; Liver fibrosis that is classified as Metavir Score ≥F3 liver disease; History of, or current evidence of, hepatic decompensation; Exclusionary screening laboratory values include: a. Aspartate aminotransferase (AST) >8×ULN, b. Bilirubin (total, direct) >1.2×ULN (unless Gilbert's syndrome is suspected) c. International Normalization Ratio (INR) >1.2×ULN; History or current evidence of cirrhosis; Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.