HBsAg Declined Patients Follow-up Study
Recruiting · NCT05977283 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nanfang Hospital, Southern Medical University
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Nanfang Hospital, Southern Medical University - Guangzhou, Guangdong, China