Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT06963710

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)

Led by Aligos Therapeutics · Updated on 2026-05-01

200

Participants Needed

58

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 65 years with a body mass index (BMI) between 18.0 and 35.0 kg/m2
  • HBeAg-positive and anti-HBeAg negative for Part 1, or HBeAg-negative for Part 2
  • Hepatitis B surface antigen (HBsAg) at or above the lower limit of quantification
  • HBV DNA level at or above 20,000 IU/mL
  • Clinical diagnosis of chronic HBV infection with ALT values less than or equal to 8 times the upper limit of normal during screening
  • Never treated with HBV antiviral medicines or investigational agents, or not treated with such medicines for at least 6 months or 5 half-lives before randomization
Not Eligible

You will not qualify if you...

  • Co-infection with hepatitis A, C, D, E, HIV, or other significant liver diseases 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 (hepatocellular carcinoma) on ultrasound
  • Received any investigational drug or device within 4 weeks or 5 half-lives before first study dose
  • Laboratory abnormalities including AST greater than 8 times upper limit of normal, bilirubin over 1.2 times upper limit of normal (unless Gilbert's syndrome suspected), or INR over 1.2 times upper limit of normal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

A

Aligos Therapeutics

CONTACT

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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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) | DecenTrialz