Follow-up of patients with decreased HBsAg levels in chronic hepatitis B

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to prospectively follow chronic hepatitis B patients who have experienced a decline in HBsAg levels over the past 12 months. The study will document treatment patterns and their impact on HBsAg loss, regardless of whether patients received new molecular entities therapy. Participants will be monitored for 36 months, with the possibility of extending the follow-up period based on study objectives. The study is non-interventional, meaning that treatment decisions will be made by the treating physician according to routine clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: jinlin hou, Master — Nanfang Hospital, Southern Medical University
• Study coordinator: Xieer Liang, M.D.
• Email: freeliang@163.com
• Phone: +862062787432

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.