Status:
NOT_YET_RECRUITING
A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
Lead Sponsor:
Ausper Biopharma Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is an open-label, multicenter phase II clinical study to evaluate the efficacy and safety of AHB-137 injection in participants with CHB previously treated with NA.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07137910
Start Date
August 27 2025
End Date
June 1 2027
Last Update
August 22 2025
Active Locations (1)
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1
AusperBio Investigational Site
Jilin, Changchun, China