AzTrials
AzTrials

Chronic Hepatitis B InfectionPhase 2B-SUPREMENCT06963710

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)

A Phase 2 study testing ALG-000184 and TDF in people with Chronic Hepatitis B Infection, run by Aligos Therapeutics at 41 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis B Infection
What is being tested?
ALG-000184 and TDF
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
41 sitesin 14 countries
Study dates
15 Jul 2025to Aug 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

41 sites in 14 countries.

41 sites in 14 countries

China7 sites

  • Aligos Investigational Sites

    Beijing

  • Aligos Investigational Site

    Changchun

  • Aligos Investigational Site

    Chengdu

  • Aligos Investigational Site

    Chongqing

  • Aligos Investigational Sites

    Guangzhou

  • Aligos Investigational Site

    Nanjing

  • Aligos Investigational Sites

    Shanghai

Other trials in China

United States6 sites

  • Aligos Investigational Site

    Coronado, California, 92118

  • Aligos Investigational Site

    Miami, Florida, 33136

  • Aligos Investigational Site

    Pasadena, California, 91105

  • Aligos Investigational Site

    Rialto, California, 92377

  • Aligos Investigational Site

    San Francisco, California, 94117

  • Aligos Investigational Site

    San Jose, California, 95116

Other trials in United States

South Korea5 sites

  • Aligos Investigational Site

    Ansan

  • Aligos Investigational Site

    Busan

  • Aligos Investigational Sites

    Seoul

  • Aligos Investigational Site

    Ulsan

  • Aligos Investigational Site

    Yangsan

Other trials in South Korea

Taiwan5 sites

  • Aligos Investigational Site

    Chiayi City

  • Aligos Investigational Site

    Kaohsiung City

  • Aligos Investigational Site

    Taichung

  • Aligos Investigational Site

    Tainan

  • Aligos Investigational Site

    Taipei

Other trials in Taiwan

Canada4 sites

  • Aligos Investigational Site

    Edmonton

  • Aligos Investigational Site

    Ottawa

  • Aligos Investigational Site

    Toronto

  • Aligos Investigational Sites

    Vancouver

Other trials in Canada

France4 sites

  • Aligos Investigational Site

    Clichy

  • Aligos Investigational Site

    Limoges

  • Aligos Investigational Site

    Nice

  • Aligos Investigational Site

    Toulouse

Other trials in France

United Kingdom3 sites

  • Aligos Investigational Site

    Glasgow

  • Aligos Investigational Site

    Leicester

  • Aligos Investigational Sites

    London

Other trials in United Kingdom

Bulgaria1 site

  • Aligos Investigational Sites

    Sofia

Other trials in Bulgaria

Hong Kong1 site

  • Aligos Investigational Sites

    Hong Kong

Other trials in Hong Kong

Italy1 site

  • Aligos Investigational Site

    Milan

Other trials in Italy

Moldova1 site

  • Aligos Investigational Site

    Chisinau

Other trials in Moldova

New Zealand1 site

  • Aligos Investigational Site

    Auckland

Other trials in New Zealand

Romania1 site

  • Aligos Investigational Sites

    Bucharest

Other trials in Romania

Spain1 site

  • Aligos Investigational Site

    Pontevedra

Other trials in Spain

About this study

Official title: 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)

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.

Read the detailed description

This is a randomized, double-blind, active-controlled, multicenter Phase 2 study to evaluate the efficacy and safety of 48 weeks of oral (PO) once daily (QD) monotherapy with ALG-000184 versus TDF in treatment naive (TN) or currently not treated (CNT) HBeAg-positive and HBeAg-negative subjects with chronic HBV infection (inclusive of chronic infection and/or chronic hepatitis).

A total of approximately 200 eligible subjects will be enrolled across 2 study parts. Part 1 will be an evaluation of HBeAg-positive subjects with chronic HBV infection and Part 2 will be an evaluation of HBeAg-negative subjects with chronic HBV infection. Each study part will consist of a main study and an exploratory liver biopsy sub-study.

Following the 48-week double-blind dosing period (Week 48), all participating subjects (in Parts 1 and 2) will be allowed to roll over into a 48 week (i.e., Week 48-96) open-label treatment extension period where they will all receive ALG-000184 monotherapy.

Being tested
ALG-000184, TDF
Keywords
Capsid Assembly Modulators, CAMs, CHB, HBV, Chronic Hepatitis B, Hepatitis B Infection, Hepatitis B
Medical subject headings
Hepatitis B, Chronic, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ALG-000184Drug

    300 mg tablet

  • TDFDrug

    300 mg tablet

Study groups in NCT06963710
Study groupRoleWhat they receive
ALG-000184ExperimentalOrally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.
Receives: Drug: ALG-000184
TDFActive comparatorOrally for 48 weeks followed by open-label treatment with ALG-000184 for 48 weeks.
Receives: Drug: TDF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected)

    HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected) at Week 48

    Measured: 48 weeks

  2. HBeAg negative: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected)

    HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target not detected) at Week 48

    Measured: 48 weeks

Secondary outcomes (16)

  1. Safety and Tolerability

    Number of participants with Treatment Emergent Adverse Events (TEAEs), with abnormal 12-lead electrocardiogram readings and abnormal clinical laboratory results.

    Measured: 96 Weeks

  2. HBV DNA levels

    Categorized by HBV DNA ≥ Lower Limit of Quantification [LLOQ], HBV DNA <Lower Limit of Quantification [LLOQ] (target detected), and HBV DNA < Lower Limit of Quantification [LLOQ] (target not detected)

    Measured: 48 weeks

  3. HBV DNA < lower limit of quantification [LLOQ] (target detected or target not detected) [HBeAg positive]

    HBV DNA < Lower Limit of Quantification [LLOQ] (target detected or target not detected) at various time points during the first 48 weeks

    Measured: 48 weeks

  4. HBV DNA < Lower Limit of Quantification [LLOQ] (target not detected) [HBeAg negative]

    HBV DNA < Lower Limit of Quantification [LLOQ] (target not detected) at various time points during the first 48 weeks

    Measured: 48 weeks

  5. Change in HBV DNA levels from baseline

    Change from baseline in HBV DNA at various time points during the first 48 weeks.

    Measured: 48 weeks

  6. Time to HBV DNA level <Lower Limit of Quantification [LLOQ]

    Time to HBV DNA < Lower Limit of Quantification [LLOQ] (target detected or target not detected) (HBeAg positive) and HBV DNA < Lower Limit of Quantification [LLOQ] (target not detected) (HBeAg negative)

    Measured: 96 Weeks

  7. Change in HBV RNA levels from baseline

    Change from baseline in HBV RNA levels at various time points during the first 48 weeks

    Measured: 48 weeks

  8. Time to HBV RNA level <Lower Limit of Quantification [LLOQ]

    Time to HBV RNA < Lower Limit of Quantification [LLOQ]

    Measured: 96 Weeks

  9. Subjects with abnormal ALT at baseline who have normal ALT at Week 48

    Subjects with abnormal ALT at baseline who have normal ALT at Week 48

    Measured: 48 weeks

  10. Emergence of treatment associated mutations in the HBV genome

    Emergence of treatment associated mutations in the HBV genome

    Measured: 96 Weeks

  11. PK parameters of ALG-001075

    PK parameters of ALG-001075 including the trough plasma concentration (Ctrough)

    Measured: 96 Weeks

  12. PK parameters of ALG-001075

    PK parameters of ALG-001075 including the time to reach the maximum plasma concentration (Tmax)

    Measured: 96 Weeks

  13. PK parameters of ALG-001075

    PK parameters of ALG-001075 including the maximum drug concentration (Cmax)

    Measured: 96 Weeks

  14. PK parameters of ALG-001075

    PK parameters of ALG-001075 including the minimum drug concentration (Cmin)

    Measured: 96 Weeks

  15. PK parameters of ALG-001075

    PK parameters of ALG-001075 including the area under the plasma concentration-time curve steady state (AUCss)

    Measured: 96 Weeks

  16. PK parameters of ALG-001075

    PK parameters of ALG-001075 including the half-life

    Measured: 96 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start15 Jul 2025
  3. Primary completionMar 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06963710
Sponsor's protocol ID
ALG-000184-202
Acronym
B-SUPREME
Status last verified
Apr 2026
First submitted
22 Apr 2025
Last updated
11 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALG-000184 and TDF in people with Chronic Hepatitis B Infection, run by Aligos Therapeutics at 41 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in China, United States, South Korea, Taiwan, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HBeAg positive: HBV DNA <Lower Limit of Quantification [LLOQ] (10 IU/mL, target detected or target not detected) (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06963710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in