B-SUPREME
Research type
Research Study
Full title
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).
IRAS ID
1012192
Contact name
Anthony Lee
Contact email
Sponsor organisation
Aligos Therapeutics, Inc.
Research summary
This is a study in participants with Chronic Hepatitis B Virus (HBV) infection. HBV infection is a serious liver disease caused by the hepatitis B virus (HBV). The virus uses its genetic material to replicate within the human body. The drug being tested in this study works by disrupting this genetic material and the replication process, reducing the amount of virus in the bloodstream. Thus, the study drug may manage the chronic HBV infection and aid in recovery from chronic HBV infection.
The purposes of this study are:
• to assess and compare the study drug, ALG-000184, with Tenofovir Disoproxil Fumarate (TDF) in treating chronic HBV infection.
• to evaluate the safety and efficacy of ALG-000184.
• to understand how ALG-000184 is changed over time and eliminated from the body.
• to evaluate the effect of ALG-000184 on the immune system and compare it with TDF.
• to evaluate the impact of ALG-000184 on biomarkers (biological indicators of disease status).
This study is divided into two parts (the main study and a sub study). Approximately 170 participants will take part in the main study. A separate sub study will be conducted at pre-selected study sites with approximately 24 participants who will undergo liver biopsies (a medical test where a doctor takes a very small piece of the participant’s liver to look at it under a microscope).
The study procedures and tests will include physical examinations, vital signs measurements, Electrocardiograms, Fibroscan (a test that uses sound waves to check how stiff the liver is), liver ultrasound, and blood and urine collection for standard laboratory blood tests.
The Sponsor of the study is Aligos Therapeutics, Inc.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0176
Date of REC Opinion
9 Jul 2025
REC opinion
Further Information Favourable Opinion