Suspended

AHB-137 for Chronic Hepatitis B with Low Viral Load

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What is being tested

AHB-137

+ NAs

+ Placebo

Drug
Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

From 18 to 65 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2024
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: December 13, 2024

Actual date on which the first participant was enrolled.

This study is focused on testing a new treatment called AHB-137 for people who have chronic hepatitis B and have not received any treatment before. It targets individuals with a low viral load of the hepatitis B virus in their blood. The goal is to understand how effective and safe AHB-137 is in managing the infection. This research is important because finding a reliable and safe treatment could significantly improve the health and quality of life for those living with chronic hepatitis B. Participants in the study will be divided into two groups; one group will receive the AHB-137 treatment, while the other will receive a placebo. The treatment is given over a period of 16 weeks, and the entire study lasts around 44 weeks, including a screening phase and a follow-up phase. Researchers will measure how well the treatment works and its safety by monitoring the participants' responses to the drug and any side effects. The study aims to gather valuable data that could lead to better treatment options for chronic hepatitis B in the future.

Official TitleA Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With CHB
NCT06829329
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

105 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

8 inclusion criteria required to participate
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;
Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive);
Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or NAs ;
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17 exclusion criteria prevent from participating
Clinically significant abnormalities except chronic HBV infection;
Any clinically significant liver diseases;
Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment;
Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
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Study Plan

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

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

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 4 locations

Suspended

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, ChinaOpen The Second Affiliated Hospital of Chongqing Medical University in Google Maps
Suspended

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, China
Suspended

The Third People's Hospital of Zhenjiang

Zhenjiang, China
Suspended

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China
Suspended4 Study Centers