NCT06963710Active, not recruitingPhase 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)
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)
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 22 Apr 2025
- Start date
- 15 Jul 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Aligos Therapeutics
- Diseases
- Hepatitis B
- NCT number
- NCT06963710
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 200
- From 15 Jul 2025 to the primary completion date, Mar 2027
- 41 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
Lab values
- Exclusionary screening laboratory values include:
- Aspartate aminotransferase (AST) \>8×ULN,
- Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
- International Normalization Ratio (INR) \>1.2×ULN
Other
- History or current evidence of cirrhosis.
- Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
Who the study is looking for
- 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).
- 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 an ALT values of ≤8×ULN during screening.
- Must have the following chronic hepatitis B virus infection treatment status at screening:
- 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
- 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).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.