Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic… (NCT06829329) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)
China105 participantsStarted 2024-12-13
Plain-language summary
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.
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:
* 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 immuno…
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 achieving HBsAg lower than limit of detection (LOD) (0.05 IU/mL) and HBV DNA lower than lower limit of quantitation (LLOQ).