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New shot aims to silence hepatitis b virus
NCT ID NCT06993480
First seen Jun 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times
Summary
This study tests an injection called AHB-137 in 20 adults with chronic hepatitis B who are already on standard antiviral pills. The goal is to see if the drug can lower or eliminate hepatitis B surface antigen (HBsAg) and viral DNA, potentially leading to a functional cure. Participants receive weekly injections for 24 weeks, and researchers monitor immune responses and safety.
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, where the virus is suppressed without lifelong medication.
- What could go wrong
- This is a small, early-phase trial with only 20 participants. It may not show strong enough antiviral effects, and risks include injection site reactions or immune-related side effects.
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
-
20 people
The number who actually took part.
- Started
-
Jul 2025
- Expected to finish
-
Nov 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 to 55 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 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: * Voluntarily participated in the study and signed an informed consent form; * Aged between 18 and 55 years at the time of signing the informed consent form; * Body mass index (BMI) within the range of 18-30 kg/ m2; * HBeAg negative or positive at screening; * HBsAg or HBV DNA positive for at least 6 months; * Have been on continuous nucleos(t)ide analogues antiviral therapy for more than 6 months prior to screening; * 100 IU/mL \< HBsAg ≤ 3000 IU/mL and HBV DNA \< 100 IU/mL at screening; * Alanine aminotransferase (ALT) ≤ 2 × upper limit of normal (ULN); * Effective contraception as required. Exclusion Criteria: * Clinically significant abnormalities other than a history of CHB infection; * Concomitant clinically significant other liver diseases; * Any serious infection other than CHB infection requiring intravenous anti-infective therapy within 1 month prior to screening; * Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive; * Liver stiffness value (LSM) \> 9.0 kPa at screening; * Diagnosis or suspicion of hepatocellular carcinoma, or alpha-fetoprotein (AFP) concentration ≥ 20 ng/mL at screening; * Participants with confirmed or suspected hepatic decompensated hepatitis B cirrhosis; * Liver biopsy at screening assessed severity of activity ≥ G3 grade and/or fibrosis reaching S4 stage; * History of extrahepatic disease possibly related to HBV immune status; * Ongoing or taking any immunosuppressive medication within 3 months prior to screening. Those who have used immunomodulators and cytotoxic drugs within 6 months prior to the first dose, or have a history of vaccination within 1 month prior to screening or have a live vaccination plan during the trial; Continuous use of traditional Chinese medicine for more than 2 months within 1 year prior to screening, or within 1 month prior to screening; Ongoing use of anticoagulants, bleeding tendency or coagulopathy, or conditions that, in the opinion of the investigator, increase the risk of liver biopsy; * Receiving or using any interferon-containing therapy within 12 months prior to screening; * History of malignancy within 5 years prior to screening or being evaluated for possible malignancy; * Suspected history of allergy to any component of the study drug, or allergic constitution (multiple drug and food allergy, and judged by the investigator to be clinically significant); * Major trauma or major surgery within 3 months prior to screening, or planned surgery during the study; * Donation or blood loss ≥ 400 mL, or received blood transfusion within 12 weeks prior to screening; Or blood donation or blood loss ≥ 200 mL within 1 month prior to screening; * Participants who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Received any antisense oligonucleotides (ASO) or using any small molecule interfering ribonucleic acid (siRNA) drug within 12 months prior to screening; * Participants with abnormal thyroid function judged by the investigator to be ineligible for enrollment; * Obviously abnormal laboratory test results; * History of vasculitis or signs and symptoms of underlying vasculitis; * 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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Other studies related to the condition(s) this trial covers.
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