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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• AusperBio Investigational Site
  Beijing, Beijing Municipality, China Recruiting
• AusperBio Investigational Site
  Jilin City, Changchun, China Recruiting
• AusperBio Investigational Site
  Xiamen, Fujian, China Recruiting
• AusperBio Investigational Site
  Nanning, Guangxi, China Recruiting
• AusperBio Investigational Site
  Chongqing, Chongqing Municipality, China Not yet recruiting
• AusperBio Investigational Site
  Chongqing, Chongqing Municipality, China Not yet recruiting

Study contacts

• Principal investigator: Junqi Niu — The First Hospital of Jilin University
• Study coordinator: Lu
• Email: clinicaltrial@ausperbio.com
• Phone: 0571-86959519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• AHB-137 injection in people with chronic hepatitis B

  This study tests AHB-137 vs placebo in adults with chronic hepatitis B who have not yet received antiviral treatment.

  Recruiting at 34 sites Phase 2 Ausper Biopharma Co., Ltd. · Beijing, Beijing Municipality and 33 other locations · NCT07635186

• AHB-137 injection pharmacokinetics and safety in people with mild to moderate liver dysfunction and normal liver function

  This study tests how AHB-137 behaves in the body and its safety in adults with chronic hepatitis B who have mild to moderate liver problems or normal liver function.

  Recruiting Phase 1 Ausper Biopharma Co., Ltd. · Chongqing, Chongqing Municipality and 4 other locations · NCT07600788

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.