NCT05977283 HBsAg Declined Patients Follow-up Study
| NCT ID | NCT05977283 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Hepatitis B |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-11 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-05-11 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
jinlin hou, Master
PRINCIPAL INVESTIGATOR
Nanfang Hospital, Southern Medical University
Frequently Asked Questions
Who can join the NCT05977283 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Hepatitis B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05977283 currently recruiting?
Yes, NCT05977283 is actively recruiting participants. Contact the research team at freeliang@163.com for enrollment information.
Where is the NCT05977283 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05977283 clinical trial?
NCT05977283 is sponsored by Nanfang Hospital, Southern Medical University. The principal investigator is jinlin hou, Master at Nanfang Hospital, Southern Medical University. The trial plans to enroll 100 participants.