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New combo aims to cure hepatitis b without lifelong pills

NCT ID NCT07069569

Disease control Sponsor: Ausper Biopharma Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a new drug called AHB-137, given alongside a hepatitis B vaccine or peginterferon, in 200 adults with chronic hepatitis B who are already on antiviral pills. The goal is to see if the combination can clear the hepatitis B surface antigen (HBsAg) from the blood, allowing patients to safely stop their daily antivirals. Participants will be monitored for 24 weeks after stopping all treatment to check if the virus stays undetectable.

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 injection, hepatitis B vaccine, pegylated interferon α-2b
What this could lead to
If successful, this combination could help people with chronic hepatitis B stop long-term antiviral medication and achieve a functional cure (no detectable virus).
What could go wrong
This is an early Phase 2 trial with only 200 participants, so results may not apply to everyone. The treatment involves multiple drugs and may cause side effects like flu-like symptoms or injection reactions.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jan 2028

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; * 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.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

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

Chronic hepatitis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AusperBio Investigational Site

    RECRUITING

    Chongqing, Chongqing Municipality, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Fuzhou, Fujian, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Guangzhou, Guangdong, China

  • AusperBio Investigational Site

    RECRUITING

    Guangzhou, Guangdong, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Shenzhen, Guangdong, China

  • AusperBio Investigational Site

    RECRUITING

    Shenzhen, Guangdong, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Zunyi, Guizhou, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Wuhan, Hubei, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Changchun, Jilin, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Chengdu, Sichuan, China

  • AusperBio Investigational Site

    RECRUITING

    Chengdu, Sichuan, China

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Kunming, Yunnan, China

    Contact Email: •••••@•••••

  • AusperBio Investigational Site

    RECRUITING

    Hangzhou, Zhejiang, China

    Contact Email: •••••@•••••

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, China

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