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Recruiting NCT07137910

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

Conditions: Chronic Hepatitis B

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 200
Sponsor: Ausper Biopharma Co., Ltd.

Location: AusperBio Investigational Site Beijing Beijing Municipality

Summary

This is an open-label, multicenter, Phase 2 study designed to evaluate the efficacy and safety of AHB-137 injection in participants with chronic hepatitis B (CHB) with low hepatitis B surface antigen (HBsAg) levels.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07137910). StuddyBuddy aggregates publicly available trial information.