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New drug aims to cure chronic hepatitis b in landmark trial

NCT ID NCT06829329

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This Phase 2 trial tests an experimental drug called AHB-137 in 105 adults with chronic hepatitis B who have not been treated before. The goal is to see if the drug can clear the hepatitis B surface antigen and lower the virus to undetectable levels, potentially leading to a functional cure. Participants will receive AHB-137, standard antivirals, or a placebo, and be followed for safety and effectiveness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AHB-137 (an experimental drug)
What this could lead to
If successful, this could point toward a functional cure for chronic hepatitis B, where the virus is suppressed and treatment can be stopped.
What could go wrong
This is an early Phase 2 trial with only 105 participants. The drug may not work as hoped, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

105 people

The number who actually took part.

Started

Dec 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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; * 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 ; * At screening, ALT\<3×upper limit of normal (ULN); * Use effective contraception as required; * HBV DNA within the specified range at screening; * HBsAg was within the specified range at screening. Exclusion Criteria: * 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; * Hepatobiliary neoplasm malignant; * The laboratory examination results are obviously abnormal; * History of vasculitis or signs and symptoms of potential vasculitis; * Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening. * History of extrahepatic disease that may be related to HBV immune status; * Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study; * History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period; * Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants; * Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study; * Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening; * Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs; * Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AusperBio Investigational Site

    Guangzhou, Guangdong, China

  • AusperBio Investigational Site

    Changzhou, Jiangsu, China

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 401336, China

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.