Suspended

AHB-137 Injection and Hepatitis B Drugs for HBeAg-Negative Chronic Hepatitis B

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What is being tested

AHB-137

+ Peg-IFN

+ Hepatitis B Vaccine

Drug
Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorAusper Biopharma Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 30, 2025

Actual date on which the first participant was enrolled.

This clinical study is focused on finding the best way to treat people with a specific type of chronic hepatitis B, where the virus does not produce a particular protein called HBeAg. The study involves patients who are already using medications known as nucleos(t)ide analogues (NAs). Researchers are testing the effects of an injection called AHB-137, either combined with a hepatitis B vaccine or another drug called Pegylated Interferon α-2b (Peg-IFN). This research is important because it aims to find more effective treatment strategies and improve the lives of people living with this form of hepatitis B. Participants in this study will receive the AHB-137 injection along with either the hepatitis B vaccine or Peg-IFN. The study is designed to see how well these combinations work and how safe they are for the participants. By monitoring how patients respond to the treatments, researchers will gather valuable information about the efficacy of these combinations. Although the study doesn’t specify particular risks or benefits, the main goal is to ensure that the treatments are both effective and safe for those involved.

Official TitleA Randomized, Open-Label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Combination With Hepatitis B Vaccine or Pegylated Interferon α-2b (Peg-IFN) in Participants With HBeAg-Negative Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogue (NAs)
NCT07069569
Principal SponsorAusper Biopharma Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

127 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis BHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus DiseasesHepadnaviridae InfectionsHepatitis B, ChronicDisease Attributes

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Beijing Friendship Hospital, Capital Medical University

Beijing, ChinaOpen Beijing Friendship Hospital, Capital Medical University in Google Maps
SuspendedOne Study Center