NCT06829329Active, not recruitingPhase 2
Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)
A Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With CHB
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 105 (actual)
- First submitted
- 11 Feb 2025
- Start date
- Dec 2024
- Primary completion date
- Aug 2026
- Lead sponsor
- Ausper Biopharma Co., Ltd.
- Diseases
- Hepatitis B
- NCT number
- NCT06829329
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 105
- From Dec 2024 to the primary completion date, Aug 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment;
- 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;
- 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;
Other illness
- Clinically significant abnormalities except chronic HBV infection;
- Any clinically significant liver diseases;
- Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
- Hepatobiliary neoplasm malignant;
- History of vasculitis or signs and symptoms of potential vasculitis;
- History of extrahepatic disease that may be related to HBV immune status;
- 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;
- Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.
Lab values
- The laboratory examination results are obviously abnormal;
- Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Changzhou | China | Unknown status |
| The Second Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Mengchao Hepatobiliary Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Third People's Hospital of Zhenjiang Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.