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

Not Applicable

Not yet recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: AHB-137

• Registration Number: NCT07137910
• Lead Sponsor: Ausper Biopharma Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-15
• Study First Submitted QC: 2025-08-15
• Last Update Submitted: 2025-08-15
• Study First Posted: 2025-08-22
• Last Update Posted: 2025-08-22
• Study Start: 2025-08-27
• Primary Completion: 2026-01-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Relevant drug treatment group	AHB-137	-
No relevant drug treatment group	AHB-137	-

Primary Outcome Measures

Name	Time	Method
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.	At the 24th week after all treatment for CHB was discontinued

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with persistent HBV DNA < LLOQ .	During the 24-week period after discontinuation of all CHB treatment
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ).	Up to 60 weeks
Detection of the concentration of HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBeAb,and HBeAg.	Up to 60 weeks
Relapse rate and time after discontinuation of NAs therapy.	Up to 60 weeks
Changes of the score of Health-Related Quality of Life (HBQOL) in participants compared with baseline.	Up to 60 weeks
Changes of the score of EuroQol Five-Dimension Five-Level Scale (EQ-5D-5L) in participants compared with baseline.	Up to 60 weeks
Number and percentage of participants with detectable anti-drug antibodies (ADA).	Up to 60 weeks
Sequencing of the Viral DNA and/or viral RNA analysis for detection of drug resistance in the target region of AHB-137.	Up to 60 weeks
Safety: Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant examination results.	Up to 60 weeks	Examination including laboratory examination, electrocardiogram (ECG) examination.
Plasma concentrations of AHB-137.	Up to 60 weeks

Trial Locations

Locations (1)

AusperBio Investigational Site; 🇨🇳 Jilin, Changchun, China