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New shot aims to cure chronic hepatitis b – early trial underway

NCT ID NCT06550128

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Updated 5 times

Summary

This study tests a new drug called AHB-137 in 86 adults with chronic hepatitis B who are already on standard antiviral pills. The goal is to see if AHB-137 can clear the hepatitis B surface antigen from the blood, which would mean the virus is under control and patients might be able to stop their daily medication. Participants receive injections of AHB-137 or a placebo over several weeks, and researchers monitor 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 injection
What this could lead to
If successful, this could point toward a functional cure for chronic hepatitis B, allowing patients to stop long-term antiviral medication.
What could go wrong
This is an early Phase 2 trial with only 86 participants. The drug may not achieve sustained viral clearance, and side effects are still being evaluated.

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

86 people

The number who actually took part.

Started

Jul 2024

Finished

Jan 2026

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: 1. Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study and discontinue their NA therapy according to the protocol; 2. At least 18 years old at the time of signing of the informed consent; 3. Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive) ; 4. Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening; 5. Participants whose serum HBsAg positive for at least 6 months prior to screening; 6. Participants who have stable on NA therapy at least 6 months prior to screening; 7. Participants with HBsAg concentration \>100 IU/mL and≤3000 IU/mL, HBV DNA\<100 IU/mL; 8. Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN); 9. For women of childbearing potential, she should be non-pregnant or non-lactating during screening, and participants (and partners) are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing. Exclusion Criteria: 1. Clinical significant abnormalities except Chronic HBV infection, such as acute coronary syndrome within 6 months before screening, evidence of major surgery, major or unstable heart disease, bleeding tendency or significant coagulation disorder within 3 months before screening; 2. Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Drug-induced liver injury, etc.; 3. Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization; 4. Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive; 5. Liver stiffness measurement (LSM) \> 9.0 kPa when screening; 6. Diagnosed or suspected hepatocellular carcinoma; 7. The laboratory examination results are obviously abnormal; 8. History of vasculitis or signs and symptoms of potential vasculitis; 9. History of extrahepatic disease that may be related to HBV immune status; 10. 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. 11. Administration of any Interferon within 6 months prior to screening; 12. History of malignant tumor within the past 5 years; 13. 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; 14. Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study; 15. 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; 16. Concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days; 17. Any oligonucleotide or siRNA treatments within 12 months prior to first dosing; 18. 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

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, China

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, China

  • The First Hospital of Jilin University

    Jilin City, China

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, China

  • The third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu, China

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