A 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)
This is a Phase 2 study to evaluate efficacy and safety of 48 weeks of oral once daily monotherapy with ALG-000184 versus tenofovir disproxil fumarate (TDF) for chronic HBV infection.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria:
1. 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).
2. HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).
3. HBsAg ≥LLOQ.
4. HBV DNA ≥20,000 IU/mL.
5. A history of a clinical diagnosis of chronic HBV infection AND an ALT values of ≤8×ULN during screening.
6. Must have the following chronic hepatitis B virus infection treatment status at screening:
1. 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
2. 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).
Key Exclusion Criteria:
1. Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.
2. Positive for anti-HBs antibodies.
3. History or current evidence of cirrhosis.
4. Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.
5. History of, or current evidence of, hepatic decompensation.
6. Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.
7. 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
8. Exclusionary screening laboratory values include:
1. Aspartate aminotransferase (AST) \>8×ULN,
2. Bilirubin (total, direct) \>1.2×ULN (unless Gilbert's syndrome is suspected)
3. International Normalization Ratio (INR) \>1.2×ULN
Primary outcome measure(s)
HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected) — 48 weeks HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target detected or target not detected) at Week 48
HBeAg negative: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected) — 48 weeks HBV DNA \<Lower Limit of Quantification \[LLOQ\] (10 IU/mL, target not detected) at Week 48
Trial sites (41)
Facility
City
Region
Status
Aligos Investigational Site
Coronado
California
Aligos Investigational Site
Pasadena
California
Aligos Investigational Site
Rialto
California
Aligos Investigational Site
San Francisco
California
Aligos Investigational Site
San Jose
California
Aligos Investigational Site
Miami
Florida
Aligos Investigational Sites
Sofia
Bulgaria
Aligos Investigational Site
Edmonton
Canada
Aligos Investigational Site
Ottawa
Canada
Aligos Investigational Site
Toronto
Canada
Aligos Investigational Sites
Vancouver
Canada
Aligos Investigational Sites
Beijing
China
Aligos Investigational Site
Changchun
China
Aligos Investigational Site
Chengdu
China
Aligos Investigational Site
Chongqing
China
Aligos Investigational Sites
Guangzhou
China
Aligos Investigational Site
Nanjing
China
Aligos Investigational Sites
Shanghai
China
Aligos Investigational Site
Clichy
France
Aligos Investigational Site
Limoges
France
Aligos Investigational Site
Nice
France
Aligos Investigational Site
Toulouse
France
Aligos Investigational Sites
Hong Kong
Hong Kong
Aligos Investigational Site
Milan
Italy
Aligos Investigational Site
Chisinau
Moldova
Aligos Investigational Site
Auckland
New Zealand
Aligos Investigational Sites
Bucharest
Romania
Aligos Investigational Site
Ansan
South Korea
Aligos Investigational Site
Busan
South Korea
Aligos Investigational Sites
Seoul
South Korea
Aligos Investigational Site
Ulsan
South Korea
Aligos Investigational Site
Yangsan
South Korea
Aligos Investigational Site
Pontevedra
Spain
Aligos Investigational Site
Chiayi City
Taiwan
Aligos Investigational Site
Kaohsiung City
Taiwan
Aligos Investigational Site
Taichung
Taiwan
Aligos Investigational Site
Tainan
Taiwan
Aligos Investigational Site
Taipei
Taiwan
Aligos Investigational Site
Glasgow
United Kingdom
Aligos Investigational Site
Leicester
United Kingdom
+ 1 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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