Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepat… (NCT06550128) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).
China86 participantsStarted 2024-07-10
Plain-language summary
AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.
Who can participate
Age range
18 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 and discontinue their NA therapy according to the protocol;
. At least 18 years old at the time of signing of the informed consent;
. Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive) ;
. Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening;
. Participants whose serum HBsAg positive for at least 6 months prior to screening;
. Participants who have stable on NA therapy at least 6 months prior to screening;
. Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN);
Exclusion criteria
. Clinical significant abnormalities except Chronic HBV infection, such as acute coronary syndrome within 6 months before screening, evidence of major surgery, major or unstable heart disease, bleeding tendency or significant coagulation disorder within 3 months before screening;
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 < limit of detection (LOD) 0.05 International Unit/mL (IU/mL) and HBV DNA < lower limit of quantitation (LLOQ) with or without anti-HBs seroconversion at the end of treatment.
. Any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, Wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, Drug-induced liver injury, etc.;
. Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;
. Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
. Liver stiffness measurement (LSM) \> 9.0 kPa when screening;
. Diagnosed or suspected hepatocellular carcinoma;
. The laboratory examination results are obviously abnormal;
. History of vasculitis or signs and symptoms of potential vasculitis;