New shot aims to tame hepatitis b without daily pills
NCT ID NCT07654283
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
10 sites in 6 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Clinica Mangiagalli
NOT_YET_RECRUITINGMilan, Milan, 20122, Italy
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Hôpital Beaujon
NOT_YET_RECRUITINGClichy, 92118, France
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King's College Hospital
NOT_YET_RECRUITINGLondon, London, SE5 9RS, United Kingdom
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NYU Langone Health
NOT_YET_RECRUITINGNew York, New York, 10016, United States
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Stanford University
NOT_YET_RECRUITINGPalo Alto, California, 94304-1509, United States
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Texas Liver Institute
RECRUITINGSan Antonio, Texas, 78215-2100, United States
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Toronto General Hospital
NOT_YET_RECRUITINGToronto, Ontario, M5G 2C4, Canada
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University of Calgary
NOT_YET_RECRUITINGCalgary, Alberta, T2N 4N1, Canada
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University of Maryland
NOT_YET_RECRUITINGBaltimore, Maryland, 21201-1009, United States
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Vall d'Hebron Hospital
NOT_YET_RECRUITINGBarcelona, Barcelona, 8035, Spain
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