2025-521178-33-00RecruitingPhase 2
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)
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: EU CTIS (euclinicaltrials.eu) · Last updated 12 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 26 May 2025
- Start date
- 3 Dec 2025
- Lead sponsor
- Aligos Therapeutics Inc.
- Diseases
- Hepatitis B
- EU CT number
- 2025-521178-33-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 50
- 18 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis B who have not been treated recently, with HBeAg-positive disease in Part 1 and HBeAg-negative disease in Part 2.
- Age
- 18 to 65 years, with a body mass index (BMI) of 18.0 to 35.0 kg/m2.
- Sex
- Men and women can join.
- Disease stage
- Chronic hepatitis B virus infection with HBV DNA of at least 20,000 IU/mL and HBsAg at or above the lower limit of quantification (LLOQ). ALT must be 8 times the upper limit of normal (ULN) or lower. No cirrhosis, no Metavir score F3 or higher, no liver decompensation.
- Earlier treatment
- People must never have had HBV antiviral treatment (NA, interferon) or an investigational anti-HBV drug. Or they must have been off such treatment for 6 months or 5 half-lives (whichever is longer) before randomization.
- Biomarker or test result
- HBeAg-positive and HBeAb-negative (Part 1), or HBeAg-negative (Part 2). HBsAg at or above LLOQ. HBV DNA of at least 20,000 IU/mL.
Main reasons for not taking part
- Co-infection with hepatitis A, C, D, E or HIV, or other significant liver disease not caused by HBV
- Positive for anti-HBs antibodies
- Cirrhosis, Metavir score F3 or higher, or liver decompensation
- Signs of liver cancer (hepatocellular carcinoma) on liver ultrasound
- Investigational drug or device within 4 weeks (or 5 half-lives, whichever is longer) before the first dose
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) 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: 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
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.
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiprofile Hospital For Active Treatment Hadji Dimitar OOD | Sliven | Bulgaria | Recruiting |
| Tokuda Hospital | Sofia | Bulgaria | Recruiting |
| University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD | Sofia | Bulgaria | Recruiting |
| Umbal - Prof. D-R Stoyan Kirkovich AD | Stara Zagora | Bulgaria | Recruiting |
| Hospital Clinic de Barcelona | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Complexo Hospitalario Universitario De Vigo | Vigo | Spain | Recruiting |
| Hopital Beaujon | Clichy | France | Recruiting |
| Centre Hospitalier Et Universitaire De Limoges | Limoges Cedex 1 | France | Recruiting |
| Centre Hospitalier Universitaire de Nice | Nice | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes | Rennes | France | Recruiting |
| Centre Hospitalier Universitaire Rouen | Rouen | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Recruiting |
| Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes | Bucharest | Romania | Recruiting |
| Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" | Bucharest | Romania | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.