Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens
Status:
NOT_YET_RECRUITING
Trial end date:
2028-05-31
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to compare sequential PEG-IFN therapy strategies in chronic hepatitis B (CHB) patients previously treated with ASO/siRNA. The main questions it aims to answer are:
1. Does sequential PEG-IFN therapy (vs. deferred/no treatment) improve HBsAg clearance rates?
2. What are the HBsAg clearance and relapse rates after 24 weeks of PEG-IFN therapy?
3. Is intermittent PEG-IFN therapy as effective and safe as continuous therapy?
Researchers will compare:
Group A (immediate 24-week PEG-IFN + 24-week follow-up) vs. Group B (24-week observation + 24-week PEG-IFN) in Phase 1 to see if sequential PEG-IFN therapy will improve HBsAg loss rate .
Researchers will describe:
* The response rate of IFN treatment in non-responders (HBsAg-positive) in Phase 2.
* The relaspe rate of responders (HBsAg-negative).
Participants will:
Phase 1 (0-48 weeks):
* Group A: Receive PEG-IFN for 24 weeks, followed by 24-week treatment-free follow-up.
* Group B: Undergo 24-week observation, then receive PEG-IFN for 24 weeks.
Phase 2 (48-96 weeks):
* HBsAg-positive at week 48 patients either from group A or group B : Receive 24-week PEG-IFN therapy, followed by 24-week follow-up.
* HBsAg-negative at week 48 patients either from group A or group B: Enter 24-week follow-up without treatment.
All participants will undergo:
HBsAg quantification, HBV DNA, liver function, and safety monitoring (every 12 weeks).