Follows adults with chronic hepatitis B whose hepatitis B surface antigen levels dropped
Follows adults with chronic hepatitis B to see how treatment affects antigen loss.
Key facts
- Who runs it
- Nanfang Hospital, Southern Medical University
- Where
- Guangzhou, ChinaSee the site
- Trial code
- Registry title
- HBsAg Declined Patients Follow-up Study
- Status
- Recruiting
- People taking part
- 100 people, planned
- Started
- 11 May 2023
- Expected to end
- Mar 2028
- Type of study
- Observational
- Record updated
- 20 February 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis B whose HBsAg level has dropped in the past 12 months. They are followed for 36 months to see how treatment affects HBsAg loss.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Chronic hepatitis B with an HBsAg drop of at least 0.5 log10 IU/mL in the past 12 months before screening. Among all enrolled people, 70% must have a drop of at least 1 log10 IU/mL or a value of 3 log10 IU/mL or lower.
- Earlier treatment
- The drop can come from any reason, with or without new molecular entities therapy. People currently in an interventional study of hepatitis B treatment cannot join.
- Biomarker or test result
- HBsAg decline of at least 0.5 log10 IU/mL in the past 12 months.
Main reasons for not taking part
- Currently taking part in an interventional clinical study exploring HBV treatment
- Any condition that the investigator thinks makes joining the study unsafe or unsuitable
- Not able or not willing to give written informed consent and follow the study plan
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in China
- Nanfang Hospital, Southern Medical UniversityGuangzhou, ChinaContact: Xier Liang, MDTaking people
About the trial
What the trial wants to find out
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:
Read full original descriptionShow less
- 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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- An Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Hepatitis B Patients With HBsAg Decline in Past 6 Months
- Plain-language title
- Follows adults with chronic hepatitis B whose hepatitis B surface antigen levels droppedGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05977283, who can take part
- Record updated
- 20 February 2024