A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hep… (NCT07137910) | Clinical Trial Compass
RecruitingPhase 2
A Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB)
China60 participantsStarted 2025-09-04
Plain-language summary
This study is an open-label, multicenter phase II clinical study to evaluate the efficacy and safety of AHB-137 injection in participants with CHB previously treated with NA.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntarily participate in the study and sign the informed consent form;
* 18-65 years of age (including boundary values) ;
* Body mass index met the requirements;
* Participants with CHB who are HBsAg or HBV DNA positive for at least 6 months;
* Meet the relevant requirements for prior medications;
* HBsAg and HBV DNA and liver function indicators meet the requirements;
* Effective contraception as required;
Exclusion Criteria:
* Uncontrolled and stable clinically significant abnormalities other than a history of CHB infection;
* Associated liver disease;
* Any serious infection other than CHB infection requires intravenous anti-infective therapy;
* HCV RNA positive, HIV antibody positive, syphilis positive;
* Abnormal laboratory results;
* Diseases associated with vascular inflammatory conditions;
* QT interval corrected heart rate (Fridericia method) abnormal;
* History of malignancy or ongoing assessment of possible malignancy;
* History of allergies, or allergic constitution;
* Participants with recent major trauma or major surgery, or planning surgery;
* Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
* Prior/current use of prohibited medications;
* Inappropriate for participation in this trial as judged by the investigator.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of participants with persistent HBsAg < limit of detection (LOD) and HBV DNA < lower limit of quantification (LLOQ) at the 24th week after all treatment for CHB was discontinued.
Timeframe: At the 24th week after all treatment for CHB was discontinued