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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)
EU CTIS ID: 2025-521178-33-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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).
You likely can't join if
- Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
- Positive for anti-HBs antibodies.
- History or current evidence of cirrhosis.
- Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
- History of, or current evidence of, hepatic decompensation.
- Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
See the full eligibility criteria
- 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).
- Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
- Positive for anti-HBs antibodies.
- History or current evidence of cirrhosis.
- Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
- History of, or current evidence of, hepatic decompensation.
- Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- China
- United Kingdom
- New Zealand
- Taiwan
- Canada
- Moldova, Republic of
- United States
- Korea, Republic of
- Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; United Kingdom; New Zealand; Taiwan; Canada; Moldova, Republic of and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.