Clinical Trials List
2025-09-23 - 2028-02-13
Recruiting8
ICD-10B15.0
Hepatitis A with hepatic coma
ICD-9070.0
Viral hepatitis A with hepatic coma
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)
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/08/19
Investigators and Locations
Co-Principal Investigator
- 齊振達 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
膜衣錠
Active Ingredient
Tenofovir disoproxil
Dosage Form
116
Dosage
245 mg
Endpoints
•第 2 部分（HBeAg 陰性）：第 48 週時血漿 HBV DNA < LLOQ (10 IU/mL, TND)
Inclution Criteria
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).
Exclusion Criteria
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:
Aspartate aminotransferase (AST) >8×ULN,
Bilirubin (total, direct) >1.2×ULN (unless Gilbert's syndrome is suspected)
International Normalization Ratio (INR) >1.2×ULN
The Estimated Number of Participants
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Taiwan
30 participants
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Global
194 participants
