Long-term Follow-up Study to Evaluate Participants With Chronic Hepatitis B (CHB) Previously Treated With AHB-137 Injection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAusper Biopharma Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: Participants who have previously participated in AHB-137 clinical trials

Trial outcomes

Primary outcomes

1

Percentage of participants maintained complete response(defined as HBsAg < 0.05IU/mL and HBV DNA < lower limit of quantification).

Time frame
Up to 80 weeks

Secondary outcomes

1

Proportion of participants achieving and maintaining HBsAg<0.05 IU/mL.

Time frame
Up to 80 weeks
2

Time to loss of HBsAg reversion.

Time frame
Up to 80 weeks
3

Proportion and time of participants meeting certain test indicators after discontinuation of all CHB treatment.

Time frame
Up to 80 weeks
4

Serum levels of HBsAg, HBV DNA, HBV RNA, HBcrAg, HBsAb,HBeAb.

Time frame
Up to 80 weeks

Other outcomes

Sponsors and contacts

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