HBsAg Declined Patients Follow-up Study

Recruiting now

Conditions studied: Hepatitis B, Hepatitis B, Chronic

In brief

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.

Key facts

Study ID

NCT05977283

Run by

Nanfang Hospital, Southern Medical University

People needed

100

Starts

2023-05-11

Expected to finish

2028-03-01

Last updated by the study team

2024-02-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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