HBsAg Declined Patients Follow-up Study
An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months
Nanfang Hospital, Southern Medical University
100 participants
May 11, 2023
OBSERVATIONAL
Conditions
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: \- Describe treatment pattern and its impact on HBsAg loss in hepatitis B patients who had HBsAg decline in past 12 months due to any reason (with or without new molecular entities therapy). Participants will be followed up for 36 months after enrollment and may be extended upon expiration according to study objectives.
Eligibility
Inclusion Criteria2
- 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 Criteria2
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05977283