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New shot aims to tame hepatitis b without daily pills

NCT ID NCT07654283

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This phase 2 trial tests an experimental drug called AHB-137 in 70 adults with chronic hepatitis B who are already on antiviral pills. The drug is given as a shot under the skin. The goal is to see if it can lower the virus to undetectable levels and allow some people to stop their daily medication. The study is open-label, meaning everyone knows they are getting the drug, and it is not yet recruiting.

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 given as a shot under the skin)
What this could lead to
If successful, this could point toward a new way to help people with chronic hepatitis B stop their daily antiviral pills and keep the virus under control.
What could go wrong
This is an early phase 2 trial with only 70 people, so results may not apply to everyone. 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

About 70 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 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 are eligible to be included in the study only if all of the following criteria apply: 1. Adults ≥18 years of age and up to 65 years of age (inclusive) at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met. 2. Body mass index (BMI) ≤35 kg/m². 3. Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA. 4. Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization. 5. HBV DNA meeting protocol-specified virologic criteria at Screening. 6. Hepatitis B surface antigen (HBsAg) level meeting protocol-specified virologic criteria at Screening. 7. Alanine aminotransferase (ALT) meeting protocol-specified criteria at Screening. 8. Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females. 9. Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose. 10. Males and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137. Exclusion Criteria: Participants will be excluded from the study if any of the following criteria apply: 1. Clinically significant disease other than chronic hepatitis B virus (HBV) infection. 2. Concomitant clinically significant liver disease. 3. Any severe infection (other than chronic HBV infection) within 1 month prior to randomization. 4. History of immune thrombocytopenia. 5. Current suspected liver cirrhosis and/or evidence of cirrhosis by protocol-specified criteria for FibroScan® or equivalent imaging modality (e.g., ultrasound elastography); historical FibroScan® (or equivalent) results with documentation within 6 months from screening is acceptable. 6. History of liver cirrhosis defined by liver biopsy or by FibroScan® or equivalent imaging modality using protocol-specified criteria. 7. Prior history of, current diagnosis of, or suspected hepatocellular carcinoma (HCC), or alpha-fetoprotein (AFP) ≥20 ng/mL at Screening. 8. History of extrahepatic diseases potentially associated with HBV infection. 9. Laboratory evidence of active infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), or active syphilis. Participants with positive HCV or HDV serology and documented negative HCV RNA or HDV RNA, respectively, are eligible. 10. Protocol-specified abnormal laboratory values at Screening. 11. History of vasculitis or presence of signs or symptoms suggestive of vasculitis, or history or presence of diseases associated with vasculitis. 12. History of malignancy within 5 years prior to Screening, except for adequately treated non-melanoma skin cancer. Participants currently undergoing evaluation for potential malignancy are excluded. 13. History of hypersensitivity or allergy to any component of the investigational product (IP). 14. Major trauma or major surgery within 3 months prior to Screening, or planned surgery during the study period unless eligibility is confirmed by the Medical Monitor. 15. Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant compliance. 16. Female participants who are pregnant, breastfeeding, planning pregnancy during the study, or unwilling to refrain from egg donation and/or in vitro fertilization during the study. 17. Participation in another clinical trial or receipt of any investigational product prior to first dose in this study within: 1. Five half-lives (if known) or twice the duration of biological effect (if known), whichever is longer, or 2. Six months, if neither half-life nor duration of effect is known 18. Prior treatment with antisense oligonucleotides (ASOs) or small interfering RNA (siRNA)-based therapies. 19. Any of the following prior or concomitant therapies: 1. Prolonged use of immunomodulators (e.g., corticosteroids, methotrexate), cytotoxic drugs, or biologics (e.g., monoclonal antibodies) within 6 months prior to first IP administration, except for short-term treatment (≤2 weeks) or topical/inhaled corticosteroids 2. Interferon therapy within 12 months prior to first dose 3. Vaccination within 1 month prior to Screening, except for influenza or SARS-CoV-2 (COVID-19) vaccination or booster 4. Current treatment with bulevirtide 20. Requirement for long-term regular use of anticoagulants (e.g., warfarin, factor Xa inhibitors) or antiplatelet agents (e.g., clopidogrel or regular aspirin), except for low-dose aspirin. 21. Any other condition or circumstance that, in the Investigator's judgment, would make the participant unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

Blood-Borne Infections Chronic Disease chronic hepatitis B virus infection Digestive System Diseases Disease Attributes DNA Virus Infections hepatitis hepatitis B virus infection Hepatitis, Chronic Infections infectious disease liver disorder Pathologic Processes Pathological Conditions, Signs and Symptoms viral hepatitis viral infectious disease

As listed by the trial registrant

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

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

    10 sites in 6 countries. 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

  • Clinica Mangiagalli

    NOT_YET_RECRUITING

    Milan, Milan, 20122, Italy

  • Hôpital Beaujon

    NOT_YET_RECRUITING

    Clichy, 92118, France

  • King's College Hospital

    NOT_YET_RECRUITING

    London, London, SE5 9RS, United Kingdom

  • NYU Langone Health

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

  • Stanford University

    NOT_YET_RECRUITING

    Palo Alto, California, 94304-1509, United States

  • Texas Liver Institute

    RECRUITING

    San Antonio, Texas, 78215-2100, United States

  • Toronto General Hospital

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • University of Calgary

    NOT_YET_RECRUITING

    Calgary, Alberta, T2N 4N1, Canada

  • University of Maryland

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21201-1009, United States

  • Vall d'Hebron Hospital

    NOT_YET_RECRUITING

    Barcelona, Barcelona, 8035, Spain

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