New drug aims to cure chronic hepatitis b in landmark trial
NCT ID NCT06829329
First seen Jun 25, 2026 · Last updated Jul 30, 2026 · Updated 3 times
Summary
This Phase 2 trial tests an experimental drug called AHB-137 in 105 adults with chronic hepatitis B who have not been treated before. The goal is to see if the drug can clear the hepatitis B surface antigen and lower the virus to undetectable levels, potentially leading to a functional cure. Participants will receive AHB-137, standard antivirals, or a placebo, and be followed for 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 (an experimental drug)
- What this could lead to
- If successful, this could point toward a functional cure for chronic hepatitis B, where the virus is suppressed and treatment can be stopped.
- What could go wrong
- This is an early Phase 2 trial with only 105 participants. 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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105 people
The number who actually took part.
- Started
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Dec 2024
- Expected to finish
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Dec 2026
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 voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol; * Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF; * Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive); * Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or NAs ; * At screening, ALT\<3×upper limit of normal (ULN); * Use effective contraception as required; * HBV DNA within the specified range at screening; * HBsAg was within the specified range at screening. Exclusion Criteria: * Clinically significant abnormalities except chronic HBV infection; * Any clinically significant liver diseases; * Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment; * Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive; * Hepatobiliary neoplasm malignant; * The laboratory examination results are obviously abnormal; * History of vasculitis or signs and symptoms of potential vasculitis; * Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening. * History of extrahepatic disease that may be related to HBV immune status; * 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; * History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period; * 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; * Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study; * 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; * Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study; * Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs; * 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
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AusperBio Investigational Site
Guangzhou, Guangdong, China
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AusperBio Investigational Site
Changzhou, Jiangsu, China
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Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
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The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 401336, China
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The Third People's Hospital of Zhenjiang
Zhenjiang, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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