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New shot aims to cure hepatitis b without daily pills

NCT ID NCT07246889

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 2 times

Summary

This phase 3 trial tests an experimental drug called AHB-137 in 577 adults with HBeAg-negative chronic hepatitis B who are already on standard antiviral pills. Participants receive weekly injections of AHB-137 or a placebo for a set period, then stop all hepatitis B treatment. The main goal is to see if the virus stays undetectable 24 weeks after stopping all therapy, which would mean a functional cure.

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 (an experimental drug) given weekly under the skin, plus standard nucleoside analogue therapy
What this could lead to
If successful, this could offer a way to stop long-term antiviral pills and achieve a 'functional cure' where the virus is undetectable without ongoing medication.
What could go wrong
This is still an early-phase 3 trial, so results may not confirm benefit. There is a risk of side effects from the injection or that the virus returns after stopping treatment.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

577 people

The number who actually took part.

Started

Aug 2025

Expected to finish

Oct 2027

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 years and older

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; * At least 18 years of age at the time of signing the ICF; * Body mass index met the requirements; * HBeAg negative at screening; * HBsAg or HBV DNA positive for at least 6 months; * Meet relevant requirements for NAs treatment; * 100 IU/mL \< HBsAg ≤ 3000 IU/mL, HBV DNA \< 100 IU/mL and liver function indicators meet the requirements; * Effective contraception as required. Exclusion Criteria: * Clinically significant abnormalities other than a history of chronic HBV infection; * Concomitant clinically significant other liver diseases; * Previous/current manifestations of hepatic decompensation; * Significant hepatic fibrosis or cirrhosis; * Presence of protocol-specified laboratory abnormalities; * History of malignancy or ongoing assessment of possible malignancy; * Those allergic to AHB-137 or its components; * Participants with recent major trauma or major surgery, or planning surgery; * Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Prior/current use of prohibited medications; * Inappropriate for participation in this trial as judged by the investigator.

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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

Contacts and locations

Locations

  • AusperBio Investigational Site

    Hefei, Anhui, China

  • AusperBio Investigational Site

    Beijing, Beijing Municipality, China

  • AusperBio Investigational Site

    Chongqing, Chongqing Municipality, China

  • AusperBio Investigational Site

    Fuzhou, Fujian, China

  • AusperBio Investigational Site

    Xiamen, Fujian, China

  • AusperBio Investigational Site

    Lanzhou, Gansu, China

  • AusperBio Investigational Site

    Foshan, Guangdong, China

  • AusperBio Investigational Site

    Guangzhou, Guangdong, China

  • AusperBio Investigational Site

    Shenzhen, Guangdong, China

  • AusperBio Investigational Site

    Liuzhou, Guangxi, China

  • AusperBio Investigational Site

    Nanning, Guangxi, China

  • AusperBio Investigational Site

    Guiyang, Guizhou, China

  • AusperBio Investigational Site

    Zunyi, Guizhou, China

  • AusperBio Investigational Site

    Haikou, Hainan, China

  • AusperBio Investigational Site

    Zhengzhou, Henan, China

  • AusperBio Investigational Site

    Wuhan, Hubei, China

  • AusperBio Investigational Site

    Changsha, Hunan, China

  • AusperBio Investigational Site

    Nanjing, Jiangsu, China

  • AusperBio Investigational Site

    Zhenjiang, Jiangsu, China

  • AusperBio Investigational Site

    Nanchang, Jiangxi, China

  • AusperBio Investigational Site

    Changchun, Jilin, China

  • AusperBio Investigational Site

    Shenyang, Liaoning, China

  • AusperBio Investigational Site

    Shanghai, Shanghai Municipality, China

  • AusperBio Investigational Site

    Taiyuan, Shanxi, China

  • AusperBio Investigational Site

    Xi’an, Shanxi, China

  • AusperBio Investigational Site

    Chengdu, Sichuan, China

  • AusperBio Investigational Site

    Kunming, Yunnan, China

  • AusperBio Investigational Site

    Hangzhou, Zhejiang, China

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