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Hepatitis B, ChronicPhase 2NCT06550128

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

A Phase 2 study testing AHB-137 (24 weeks) and AHB-137 (16 weeks) in people with Hepatitis B, Chronic, run by Ausper Biopharma Co., Ltd. at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
AHB-137 (24 weeks) and AHB-137 (16 weeks)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
86 participants
Where
6 sitesChina
Study dates
10 Jul 2024to 26 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 years and older
  • 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 and discontinue their NA therapy according to the protocol;
  • At least 18 years old at the time of signing of the informed consent;
  • Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive) ;
  • Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening;
  • Participants whose serum HBsAg positive for at least 6 months prior to screening;
  • Participants who have stable on NA therapy at least 6 months prior to screening;
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  • Participants with HBsAg concentration >100 IU/mL and≤3000 IU/mL, HBV DNA<100 IU/mL;
  • Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN);
  • For women of childbearing potential, she should be non-pregnant or non-lactating during screening, and participants (and partners) are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing.

Who cannot join

  • Clinical significant abnormalities except Chronic HBV infection, such as acute coronary syndrome within 6 months before screening, evidence of major surgery, major or unstable heart disease, bleeding tendency or significant coagulation disorder within 3 months before screening;
  • Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Drug-induced liver injury, etc.;
  • Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;
  • Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
  • Liver stiffness measurement (LSM) > 9.0 kPa when screening;
  • Diagnosed or suspected hepatocellular carcinoma;
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  • The laboratory examination results are obviously abnormal;
  • History of vasculitis or signs and symptoms of potential vasculitis;
  • 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.
  • Administration of any Interferon within 6 months prior to screening;
  • History of malignant tumor within the past 5 years;
  • 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;
  • Concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days;
  • Any oligonucleotide or siRNA treatments within 12 months prior to first dosing;
  • 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

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian

  • Nanfang Hospital, Southern Medical University

    Guangzhou

  • The First Hospital of Jilin University

    Jilin City

  • The third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in HBeAg-negative CHB Subjects Under Stable Nucleos(t)Ide Analogue (NA) Treatment

AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.

Read the detailed description

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

Being tested
AHB-137 (24 weeks), AHB-137 and Placebo, AHB-137 (16 weeks)
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-137 (24 weeks)Drug

    AHB-137 injection will be administered subcutaneously.

  • AHB-137 and PlaceboDrug

    AHB-137and placebo will be administered subcutaneously.

  • AHB-137 (16 weeks)Drug

    AHB-137 injection will be administered subcutaneously.

Study groups in NCT06550128
Study groupRoleWhat they receive
AHB-137 (24 weeks)ExperimentalNot described
Receives: Drug: AHB-137 (24 weeks)
PlaceboPlacebo comparatorNot described
Receives: Drug: AHB-137 and Placebo
AHB-137 (16 weeks)ExperimentalNot described
Receives: Drug: AHB-137 (16 weeks)

What is being measured

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

  1. Proportion of participants achieving HBsAg < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment.

    Measured: Up to 24 weeks

Secondary outcomes (15)

  1. Proportion of participants achieving HBsAg lower than LOD and HBV DNA lower than LLOQ , regardless of whether HBsAg seroconversion is observed

    Measured: At 8 weeks

  2. Proportion of participants meeting NA treatment discontinuation criteria.

    Measured: Up to 48 weeks

  3. 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 72 weeks

  4. Percentage of participants with different levels of HBsAg reduction compared with baseline

    Measured: Up to 72 weeks

  5. Serum levels of HBV DNA, HBsAg, highly sensitive HBsAg, HBcrAg, HBV RNA, HBsAb, HBeAb and HBsAg-HBsAb.

    Measured: Up to 72 weeks

  6. The time from the discontinuation of NA treatment to virological relapse

    Measured: Up to 72 weeks

  7. The time from the discontinuation of NA treatment to clinical relapse

    Measured: Up to 72 weeks

  8. Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance of AHB-137

    Measured: Up to 24 weeks

  9. Safety: number of participants with adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results, including laboratory examination, electrocardiogram (ECG) examination, physical examination and vital signs

    Measured: Up to 72 weeks

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

    Measured: Up to 72 weeks

  11. Changes of cytokine levels compared with baseline

    Measured: Up to 72 weeks

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

    Measured: Up to 72 weeks

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

    Measured: Up to 72 weeks

  14. Plasma concentrations of AHB-137

    Measured: Up to 72 weeks

  15. Proportion of participants maintaining sustained response.

    Measured: Up to 72 weeks

Timeline

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

  1. First posted12 Aug 2024
  2. Study start10 Jul 2024
  3. Primary completion26 May 2025
  4. Study completion26 Jan 2026

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
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06550128
Sponsor's protocol ID
AB-10-8003
Status last verified
Aug 2026
First submitted
5 Aug 2024
Last updated
15 Sep 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 (24 weeks) and AHB-137 (16 weeks) in people with Hepatitis B, Chronic, 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 9 inclusion and 18 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: finished, as of the sponsor's last update on 15 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 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment. (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 NCT06550128.

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 15 Sep 2026.

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