Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Subjects With Chronic Hepatitis B (CHB).
NCT Number: NCT06550128
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Hepatitis B, Chronic
Interventions: DRUG: AHB-137 injection|DRUG: Placebo
Sponsor: Ausper Biopharma Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-05
Completion Date: 2026-06-30
Locations: Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, Fujian, China|The third People's Hospital of Zhenjiang, Zhenjiang, Jiangsu, China|Beijing Friendship Hospital, Capital Medical University, Beijing, China|The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China|Nanfang Hospital, Southern Medical University, Guangzhou, China|The First Hospital of Jilin University, Jilin, China

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.

Primary Outcome Measures: Proportion of participants achieving HBsAg lower than lower limit of quantification(LLOQ )(0.05 IU/mL) and HBV DNA lower than LLOQ , regardless of whether HBsAg seroconversion is observed, Up to 24 weeks
Secondary Outcome Measures: Proportion of participants achieving HBsAg lower than LLOQ and HBV DNA lower than LLOQ , regardless of whether HBsAg seroconversion is observed, At 8 weeks|Proportion of participants achieving sustained virologic response (SVR) measured by HBsAg and HBV DNA levels, Up to 48 weeks|Proportion of participants maintain HBsAg lower than LLOQ (0.05 IU/mL) and HBV DNA lower than LLOQ, regardless of whether HBsAg seroconversion is observed, Up to 48 weeks|Changes of the score of hepatitis B quality of life instrument (HBQOL) compared with baseline, The HBQOL consists of 31 items and 6 domains: psychological well-being, anticipation anxiety, vitality, stigma, transmissibility and vulnerability. Response options range from 1 to 5 with higher scores indicating more severe impact of Hepatitis B than lower scores., Up to 72 weeks|Percentage of participants with different levels of HBsAg reduction compared with baseline, Up to 72 weeks|Serum levels of HBV DNA, HBsAg, highly sensitive HBsAg (<0.005 IU/mL), HBcrAg, HBV RNA, HBsAb, HBeAb and HBsAg-HBsAb., Up to 72 weeks|The number and percentage of participants whose HBsAg and/or HBV DNA decreased to below the LLOQ, Up to 72 weeks|The time from the end of AHB-137 OFF treatment to virological relapse, Up to 72 weeks|The time from the end of AHB-137 OFF treatment to clinical relapse, Up to 72 weeks|Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance of AHB-137, Up to 24 weeks|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, Up to 72 weeks|Immunogenicity: number and percentage of participants with detectable anti-drug antibodies (ADA), Up to 72 weeks|Changes of cytokine levels compared with baseline, Up to 72 weeks|The pharmacokinetic profile of AHB-137: Maximum concentration (Cmax) of AHB-137 in plasma, Up to 72 weeks|The pharmacokinetic profile of AHB-137: Area under the concentration-time curve (AUC) of AHB-137, Up to 72 weeks|Plasma concentrations of AHB-137, Up to 72 weeks