Actively Recruiting
A Randomized, Double-Blind, Active-Controlled Phase 2 Study Evaluating ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adults With Chronic Hepatitis B Infection
Led by Aligos Therapeutics · Updated on 2026-05-01
200
Participants Needed
58
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of 48 weeks of daily oral treatment with ALG-000184 compared to tenofovir disproxil fumarate (TDF) in adults with chronic hepatitis B virus (HBV) infection. This Phase 2 randomized, double-blind, active-controlled study includes both untreated HBeAg-positive and HBeAg-negative adults. The study aims to understand how well these treatments control HBV infection and their safety profiles. Participants will receive either ALG-000184 or TDF tablets once daily for 48 weeks. After this double-blind period, all participants may continue treatment with open-label ALG-000184 for an additional 48 weeks, making a total treatment duration of 96 weeks. The study is divided into two parts, focusing separately on HBeAg-positive and HBeAg-negative subjects, with some taking part in an exploratory liver biopsy sub-study. Throughout the study, participants will undergo regular assessments including measuring HBV DNA levels to see if the virus is suppressed below a set detection limit at 48 weeks. Safety and tolerability will be monitored up to 96 weeks. Other evaluations include liver enzyme levels, viral resistance, and drug pharmacokinetics. The study involves blood tests, liver assessments, and ongoing monitoring to track treatment effects and participant health over nearly two years.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female between 18 and 65 years of age with a body mass index of 18.0 to 35.0 kg/m2 or minimum age by local regulations
- HBeAg-positive and anti-HBeAg negative (Part 1) or HBeAg-negative (Part 2)
- HBsAg at or above the lower limit of quantification
- HBV DNA level of at least 20,000 IU/mL
- Clinical diagnosis of chronic HBV infection with ALT values at or below 8 times the upper limit of normal during screening
- Never received treatment with HBV antiviral medicines or investigational agents, or not treated with these within 6 months or 5 half-lives before randomization
You will not qualify if you...
- Co-infection with hepatitis A, C, D, E, or HIV or any significant liver disease not caused by HBV
- Positive for anti-HBs antibodies
- History or current evidence of cirrhosis
- Liver fibrosis classified as Metavir Score F3 or higher
- History or current evidence of hepatic decompensation
- Evidence of liver cancer on ultrasound
- Received investigational medicinal product or device within 4 weeks or 5 half-lives before first study drug dose
- Laboratory exclusion values: AST greater than 8 times upper limit of normal, bilirubin over 1.2 times upper limit (except suspected Gilbert's syndrome), or INR over 1.2 times upper limit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants take oral medication once daily for 48 weeks to treat chronic Hepatitis B infection.
Weekly visits for up to 48 weeks
Duration - 48 weeks
Participants continue with open-label oral treatment once daily for an additional 48 weeks.
Visits approximately every 4 weeks for up to 48 weeks
Trial Site Locations
Total: 58 locations
1
Aligos Investigational Site
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Aligos Investigational Site
Coronado, California, United States, 92118
Actively Recruiting
3
Aligos Investigational Site
Garden Grove, California, United States, 92840
Actively Recruiting
4
Aligos Investigational Site
Los Angeles, California, United States, 90033
Actively Recruiting
5
Aligos Investigational Site
Palo Alto, California, United States, 94304
Actively Recruiting
6
Aligos Investigational Site
Pasadena, California, United States, 91105
Actively Recruiting
7
Aligos Investigational Site
Rialto, California, United States, 92377
Actively Recruiting
8
Aligos Investigational Site
San Francisco, California, United States, 94117
Actively Recruiting
9
Aligos Investigational Site
San Jose, California, United States, 95116
Actively Recruiting
10
Aligos Investigational Site
Miami, Florida, United States, 33136
Actively Recruiting
11
Aligos Investigational Site
Miami, Florida, United States, 33173
Actively Recruiting
12
Aligos Investigational Site
Marrero, Louisiana, United States, 70072
Actively Recruiting
13
Aligos Investigational Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
14
Aligos Investigational Site
Chevy Chase, Maryland, United States, 20815
Actively Recruiting
15
Aligos Investigational Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
16
Aligos Investigational Site
Manhasset, New York, United States, 10075
Actively Recruiting
17
Aligos Investigational Site
New York, New York, United States, 10016
Actively Recruiting
18
Aligos Investigational Site
Durham, North Carolina, United States, 27710
Actively Recruiting
19
Aligos Investigational Site
Sliven, Bulgaria
Actively Recruiting
20
Aligos Investigational Sites
Sofia, Bulgaria
Actively Recruiting
21
Aligos Investigational Site
Stara Zagora, Bulgaria
Actively Recruiting
22
Aligos Investigational Site
Edmonton, Canada
Actively Recruiting
23
Aligos Investigational Site
Ottawa, Canada
Actively Recruiting
24
Aligos Investigational Site
Toronto, Canada
Actively Recruiting
25
Aligos Investigational Sites
Vancouver, Canada
Actively Recruiting
26
Aligos Investigational Sites
Beijing, China
Actively Recruiting
27
Aligos Investigational Site
Changchun, China
Actively Recruiting
28
Aligos Investigational Site
Chengdu, China
Actively Recruiting
29
Aligos Investigational Site
Chongqing, China
Actively Recruiting
30
Aligos Investigational Sites
Guangzhou, China
Actively Recruiting
31
Aligos Investigational Site
Nanjing, China
Actively Recruiting
32
Aligos Investigational Sites
Shanghai, China
Actively Recruiting
33
Aligos Investigational Site
Clichy, France
Actively Recruiting
34
Aligos Investigational Site
Limoges, France
Actively Recruiting
35
Aligos Investigational Site
Nice, France
Actively Recruiting
36
Aligos Investigational Site
Rennes, France
Actively Recruiting
37
Aligos Investigational Site
Rouen, France
Actively Recruiting
38
Aligos Investigational Site
Toulouse, France
Actively Recruiting
39
Aligos Investigational Sites
Hong Kong, Hong Kong
Actively Recruiting
40
Aligos Investigational Site
Milan, Italy
Actively Recruiting
41
Aligos Investigational Site
Chisinau, Moldova
Actively Recruiting
42
Aligos Investigational Site
Auckland, New Zealand
Actively Recruiting
43
Aligos Investigational Sites
Bucharest, Romania
Actively Recruiting
44
Aligos Investigational Site
Ansan, South Korea
Actively Recruiting
45
Aligos Investigational Site
Busan, South Korea
Actively Recruiting
46
Aligos Investigational Sites
Seoul, South Korea
Actively Recruiting
47
Aligos Investigational Site
Ulsan, South Korea
Actively Recruiting
48
Aligos Investigational Site
Yangsan, South Korea
Actively Recruiting
49
Aligos Investigational Site
Barcelona, Spain
Actively Recruiting
50
Aligos Investigational Site
Pontevedra, Spain
Not Yet Recruiting
51
Aligos Investigational Site
Chiayi City, Taiwan
Actively Recruiting
52
Aligos Investigational Site
Kaohsiung City, Taiwan
Actively Recruiting
53
Aligos Investigational Site
Taichung, Taiwan
Actively Recruiting
54
Aligos Investigational Site
Tainan, Taiwan
Actively Recruiting
55
Aligos Investigational Site
Taipei, Taiwan
Actively Recruiting
56
Aligos Investigational Site
Glasgow, United Kingdom
Actively Recruiting
57
Aligos Investigational Site
Leicester, United Kingdom
Actively Recruiting
58
Aligos Investigational Sites
London, United Kingdom
Actively Recruiting
Research Team
A
Aligos Therapeutics
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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