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

Ausper Biopharma

Status: Not yet enrolling

Conditions: Chronic Hepatitis B

Study type: Observational

Funder types: Industry

Identifiers

NCT07146100

AB-10-8004

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

200 participants in 1 patient group

Participants who have previously participated in AHB-137 clinical trials