A Multicenter Study of AHB-137 Injection Combined With Other Hepatitis B Drugs

NCT ID: NCT07069569

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2027-05-01

Brief Summary

This is a randomized, open-label, multicenter phase II study to evaluate the efficacy and safety of AHB-137 injection in combination with other hepatitis B drugs in participants with HBeAg-negative CHB treated with NAs.

Conditions

Chronic Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AHB-137 (16 weeks) and Peg-IFN

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 will be injected.

Peg-IFN

Intervention Type: DRUG

Peg-IFN will be administered .

AHB-137 (24 weeks) and Peg-IFN

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 will be injected.

Peg-IFN

Intervention Type: DRUG

Peg-IFN will be administered .

AHB-137 and Hepatitis B vaccine

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 will be injected.

Hepatitis B Vaccine

Intervention Type: DRUG

Hepatitis B vaccine will be administered.

AHB-137

Group Type: EXPERIMENTAL

AHB-137

Intervention Type: DRUG

AHB-137 will be injected.

Interventions

AHB-137

AHB-137 will be injected.

Intervention Type: DRUG

Peg-IFN

Peg-IFN will be administered .

Intervention Type: DRUG

Hepatitis B Vaccine

Hepatitis B vaccine will be administered.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
• Aged between 18 and 65 years at the time of signing the ICF;
• Body mass index (BMI) within the range of 18-30 kg/ m2;
• HBeAg negative at screening;
• HBsAg or HBV DNA positive for at least 6 months;
• Continue antiviral therapy with a single nucleoside (t) ide analogue for more than 6 months prior to screening;
• Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN);
• Effective contraception as required.

Exclusion Criteria

• Participants who are not eligible for treatment with Peg-IFN/recombinant hepatitis B vaccine;
• Clinically significant abnormalities other than a history of chronic HBV infection;
• Concomitant clinically significant other liver diseases;
• Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to screening;
• HCV RNA positive, Human immunodeficiency virus (HIV) positive, syphilis positive;
• Significant liver fibrosis or cirrhosis at screening, or a liver stiffness value (LSM) > 9.0 kPa;
• Previous/current manifestations of hepatic decompensation;
• Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein concentration (AFP) ≥ 20 ng/mL at screening;
• Obviously abnormal laboratory test results;
• History of vasculitis or presence of signs, symptoms, or laboratory tests of underlying vasculitis, and previous/current other diseases that may be related to vasculitic conditions;
• QT interval corrected for heart rate (Fridericia method) abnormal;
• History of extrahepatic disease possibly related to HBV immune status;
• Participants with a history of malignancy within the past 5 years or who are being evaluated for a possible malignancy;
• Serious mental illness or history of serious mental illness prior to screening;
• Suspected history of allergy to any component of the study drug, or allergic constitution;
• Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study;
• Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
• Current use or use of any immunosuppressive medication within 3 months prior to screening, with the exception of short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose;Or a history of vaccination within 6 months prior to screening or a live vaccination plan during the trial;
• Participants requiring regular long-term administration of anticoagulants or antiplatelet drugs;
• Thyroid dysfunction;
• Patients with uncontrolled epilepsy and other progressive neurological disorders;
• Received any antisense oligonucleotides (ASO) or small molecule interfering ribonucleic acid (siRNA) drug;
• Any other circumstance or condition that, in the opinion of the investigator, the participants are inappropriate for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ausper Biopharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

AB-10-8007

Identifier Type: -

Identifier Source: org_study_id