AHB-137 injection for adults with chronic hepatitis B previously treated with nucleos(t)ide analogue antivirals

An Open-label, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B Previously Treated With Nucleos (t) Ide Analogues (NA)

This will test whether AHB-137 injection improves viral control and liver function in adults with chronic hepatitis B who were previously treated with nucleos(t)ide analogue antivirals.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Ausper Biopharma Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Jilin, Changchun)
• Trial ID: NCT07137910 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter Phase II study administering AHB-137 injections to adults with chronic hepatitis B who have prior nucleos(t)ide analogue treatment. Participants will be enrolled at the AusperBio investigational site in Changchun and followed through scheduled visits to monitor HBsAg, HBV DNA, liver function tests, and safety labs. The trial is unblinded and focuses on both efficacy signals (changes in viral markers and antigen levels) and safety/tolerability. Key eligibility requires confirmed chronic HBV infection for at least six months and specific baseline laboratory and contraception requirements.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 years old with chronic hepatitis B confirmed for at least six months who previously received nucleos(t)ide analogue therapy and meet the study's laboratory and contraception criteria.

Not a fit: Patients with other liver diseases, uncontrolled significant medical conditions, coinfections (HCV, HIV, syphilis), abnormal baseline laboratory results, pregnancy, or a history of malignancy are unlikely to benefit or may be excluded.

Why it matters

Potential benefit: If successful, AHB-137 could lower hepatitis B viral levels and improve liver function, potentially reducing reliance on long-term oral antivirals.

How similar studies have performed: AHB-137 is an experimental agent with limited published clinical data, and prior therapeutic injection approaches for chronic hepatitis B have produced mixed results.

Eligibility criteria

Inclusion Criteria:

* Voluntarily participate in the study and sign the informed consent form;
* 18-65 years of age (including boundary values) ;
* Body mass index met the requirements;
* Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
* Meet the relevant requirements for prior medications;
* HBsAg and HBV DNA and liver function indicators meet the requirements;
* Effective contraception as required;

Exclusion Criteria:

* Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
* Associated liver disease;
* Any serious infection other than CHB infection requires intravenous anti-infective therapy;
* HCV RNA positive, HIV antibody positive, syphilis positive;
* Abnormal laboratory results;
* Diseases associated with vascular inflammatory conditions;
* QT interval corrected heart rate (Fridericia method) abnormal;
* History of malignancy or ongoing assessment of possible malignancy;
* History of allergies, or allergic constitution;
* Participants with recent major trauma or major surgery, or planning surgery;
* Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
* Prior/current use of prohibited medications;
* Inappropriate for participation in this trial as judged by the investigator.

Where this trial is running

Jilin, Changchun

• AusperBio Investigational Site — Jilin, Changchun, China (Recruiting)

Study contacts

• Principal investigator: Junqi Niu — The First Hospital of Jilin University
• Study coordinator: Lu

Conditions Chronic Hepatitis B; Hepatitis B, Chronic