Status:
RECRUITING
HBsAg Declined Patients Follow-up Study
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Hepatitis B
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Brief Summary
The goal of this observational study is to prospectively follow chronic hepatitis B patients who had HBsAg decline in the past 12 months prior to screening. The main question it aims to answer are: \...
Detailed Description
This study is a retrospective and prospective follow-up study for participants who had HBsAg decline in past 6 months due to any reason (with or without new molecular entities therapy). The follow-up ...
Eligibility Criteria
Inclusion
- Participants must have HBsAg decline ≥0.5 log10 IU/mL in past 12 months prior to screening due to any reason (with or without new molecular entities therapy). Among the enrolled subjects, 70% must have HBsAg decline ≥1 log10 IU/mL or actual values ≤3 log10 IU/mL.
- Able and willing to provide written informed consent and to comply with the study protocol according to International Council for Harmonization (ICH) and local regulations.
Exclusion
- Any condition which, in the opinion of the investigator, contraindicates their participant in this study.
- Participants who are currently participating in interventional clinical study exploring HBV treatment.
Key Trial Info
Start Date :
May 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05977283
Start Date
May 11 2023
End Date
March 1 2028
Last Update
February 20 2024
Active Locations (1)
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1
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510000