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Chronic Hepatitis BPhase 2NCT06829329

Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)

A Phase 2 study testing AHB-137 and NAs in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 6 sites in China.

Active, not recruiting

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

Official record
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Trial summary

The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
AHB-137 and NAs
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
6 sitesChina
Study dates
13 Dec 2024to Dec 2026
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

  • Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
  • Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
  • Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive);
  • Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or NAs ;
  • At screening, ALT<3×upper limit of normal (ULN);
  • Use effective contraception as required;
  • HBV DNA within the specified range at screening;
  • HBsAg was within the specified range at screening.

Who cannot join

  • Clinically significant abnormalities except chronic HBV infection;
  • Any clinically significant liver diseases;
  • Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment;
  • Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
  • Hepatobiliary neoplasm malignant;
  • The laboratory examination results are obviously abnormal;
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  • History of vasculitis or signs and symptoms of potential vasculitis;
  • Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
  • History of extrahepatic disease that may be related to HBV immune status;
  • Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study;
  • History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period;
  • Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
  • Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
  • Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
  • Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
  • Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs;
  • Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • AusperBio Investigational Site

    Changzhou, Jiangsu

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 401336

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian

  • AusperBio Investigational Site

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: A Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With CHB

The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.

Being tested
AHB-137, NAs, Placebo
Keywords
Hepatitis B, Chronic
Medical subject headings
Hepatitis B, Chronic

What participants receive

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

  • AHB-137Drug

    AHB-137 will be administered .

  • NAsDrug

    NAs will be administered.

  • PlaceboDrug

    Placebo will be administered .

Study groups in NCT06829329
Study groupRoleWhat they receive
AHB-137 and placeboExperimentalNot described
Receives: Drug: AHB-137; Drug: Placebo
AHB-137 and Nucleos(t)Ide Analogue (NAs)ExperimentalNot described
Receives: Drug: AHB-137; Drug: NAs

What is being measured

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

  1. Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).

    Measured: Up to 24 weeks

Secondary outcomes (15)

  1. Proportion of participants achieving functional cure during 24 weeks after discontinuation of all CHB therapy.

    Measured: Up to 48 weeks

  2. Number of Participants With HBsAg<LOD (0.05 IU/mL) and the percentage of participants with different levels of HBsAg reduction compared with baseline.

    Measured: Up to 48 weeks

  3. Number of participants with HBV DNA<LLOQ and the percentage of participants with different HBV DNA reduction.

    Measured: Up to 48 weeks

  4. Proportion of participants achieving HBsAg<LOD and HBV DNA<LLOQ, with or without HBsAb

    Measured: Up to 48 weeks

  5. Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb

    Measured: Up to 48weeks

  6. Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline

    This scale has 31 items, including 7 dimensions: psychological status, expected anxiety, vitality, shame, infectivity, health vulnerability, and viral response. Each item is scored on a 5-point scale, with higher scores indicating a more severe impact of hepatitis B on quality of life.

    Measured: Up to 48 weeks

  7. Percentage of participants who reached HBeAg negative

    Only for participants with HBeAg positive at baseline

    Measured: Up to 48 weeks

  8. Percentage of participants achieving HBeAg seroconversion

    Only for participants with HBeAg positive at baseline

    Measured: Up to 48 weeks

  9. Proportion of participants with ALT normailzation in absence of rescue therapy.

    Only for participants with abnormal ALT at baseline

    Measured: Up to 48 weeks

  10. Time of ALT normalization in absence of rescue therapy

    Only for participants with abnormal ALT at baseline

    Measured: Up to 48 weeks

  11. Safety: number of participants with treatment-emergent adverse events (TEAEs), treatment-related adverse events(TRAEs), serious adverse events (SAE) and clinically significant examination results

    Examination including laboratory examination, electrocardiogram (ECG) examination

    Measured: Up to 48 weeks

  12. Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA)

    Measured: Up to 48 weeks

  13. The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma

    Measured: Up to 48 weeks

  14. The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137

    Measured: Up to 48 weeks

  15. Plasma concentrations of AHB-137

    Measured: Up to 48 weeks

Timeline

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

  1. First posted17 Feb 2025
  2. Study start13 Dec 2024
  3. Primary completion2 Aug 2026 (estimated)
  4. Study completionDec 2026 (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
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06829329
Sponsor's protocol ID
AB-10-8008
Status last verified
Jul 2026
First submitted
11 Feb 2025
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AHB-137 and NAs in people with Chronic Hepatitis B, run by Ausper Biopharma Co., Ltd. at 6 sites in China.

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 17 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 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. 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?

Proportion of participants achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ). (time frame: Up to 24 weeks). 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 NCT06829329.

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 29 Jul 2026.

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