Follow-up of patients with decreased HBsAg levels in chronic hepatitis B
An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months
This study is tracking people with chronic hepatitis B who have lower HBsAg levels to see how their treatment affects their condition over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05977283 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are chronic hepatitis B patients who have had an HBsAg decline of at least 0.5 log10 IU/mL in the past 12 months.
Not a fit: Patients currently participating in interventional clinical studies exploring HBV treatment may not benefit from this observational study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the treatment patterns that lead to HBsAg loss in chronic hepatitis B patients.
How similar studies have performed: While there have been studies on HBsAg decline, this specific observational approach focusing on treatment patterns is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.