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Clinical Trials List

Protocol NumberALG-000184-202

NCT Number(ClinicalTrials.gov Identfier)NCT06963710

Active

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)

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/04/10

Investigators and Locations

Principal Investigator Yi-Hsiang Huang 無

Taipei Veterans General Hospital

Co-Principal Investigator

齊振達無
吳啟榮無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳建宏無

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Jen Liu 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wan-Long Chuang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Yuan Peng 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳啟益無

Chia-Yi Christian Hosptal

Co-Principal Investigator

許銘澤無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Tsung Chang

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Hepatitis B Infection

Objectives

Chronic hepatitis B virus infection is a serious liver disease caused by the hepatitis B virus (HBV). The virus uses its genetic material to replicate in the human body. The objectives of this clinical study are: • To evaluate and compare the efficacy of the investigational drug ALG-000184 with TDF in the treatment of chronic HBV infection. • To evaluate the safety and efficacy of ALG-000184. • To understand how the investigational drug changes and is cleared from the body over time (a pharmacokinetic or PK test). • To evaluate the effects of the investigational drug on the immune system and compare them with TDF. • To evaluate the effects of the investigational drug on biomarkers (biomarkers of disease state).

Test Drug

Film-coated tablets
Film-coated tablets

Active Ingredient

ALG-000184
Tenofovir disoproxil

Dosage Form

116
116

Dosage

300 mg
245 mg

Endpoints

• Part 1 (HBeAg positive): Plasma HBV DNA at week 48 < LLOQ (10 IU/mL, TD [target detected] or TND [target not detected])

• Part 2 (HBeAg negative): Plasma HBV DNA at week 48 < LLOQ (10 IU/mL, TND)

Inclution Criteria

Key Inclusion 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

Key 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

Taiwan

30 participants
Global

194 participants