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Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens

NCT06923280 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-11

No results posted yet for this study

Summary

The goal of this clinical trial is to compare sequential PEG-IFNα 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-IFNα therapy (vs. deferred/no treatment) improve HBsAg clearance rates?
2. What are the HBsAg clearance and relapse rates after 24 weeks of PEG-IFNα therapy?
3. Is intermittent PEG-IFNα therapy as effective and safe as continuous therapy?

Researchers will compare:

• Group A (immediate 24-week PEG-IFNα + 24-week follow-up) vs. Group B (24-week observation + 24-week PEG-IFNα) in Phase 1 to see if sequential PEG-IFNα 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-IFNα for 24 weeks, followed by 24-week treatment-free follow-up.
* Group B: Undergo 24-week observation, then receive PEG-IFNα 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-IFNα 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).

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Pegylated Interferon-alpha (IFN)

pegylated interferon-alpha 180 μg once weekly for 24 weeks

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Wenghong Zhang, MD · Huashan Hospital

  • Jiming Zhang, MD · Huashan Hospital

  • Yuxian Huang, MD · Huashan Hospital

  • Feng Sun, MD · Huashan Hospital

  • Chao Qiu · Huashan Hospital

  • Chen Chen, MD · Huashan Hospital

  • Qiran Zhang, MD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2027-12-31
Completion
2028-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06923280 on ClinicalTrials.gov