About this trial
This study is a prospective, open-label, multicenter long-term follow-up study to evaluate the durability of virologic response in subjects with chronic hepatitis B previously treated with AHB-137 injection.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Capable of giving informed consent.
Participants who have previously received at least one dose of AHB-137 and achieved the complete of partial response in the parent study without rescue medication and who maintained response until the End of Study (EoS) visit in their parent study.
Disqualifiers
Participants who have/or are currently participating in another interventional clinical study since completing their treatment with AHB-137.
Suspected for cancer at screening or any condition required hospitalization during this study , or any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.
Trial population
Participants who have previously participated in AHB-137 clinical trials
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Percentage of participants maintained complete response(defined as HBsAg < 0.05IU/mL and HBV DNA < lower limit of quantification).
Secondary outcomes
Proportion of participants achieving and maintaining HBsAg<0.05 IU/mL.
Time to loss of HBsAg reversion.
Proportion and time of participants meeting certain test indicators after discontinuation of all CHB treatment.
Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAb.
Sponsors and contacts
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