Status:
NOT_YET_RECRUITING
Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens
Lead Sponsor:
Huashan Hospital
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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: ...
Eligibility Criteria
Inclusion
- Age ≥18 years.
- Chronic HBV infection (documented HBsAg positivity for \>6 months).
- Prior participation in ASO or siRNA clinical trials:
- Received ≥1 dose of ASO/siRNA (or matched placebo, if applicable).
- Achieved ≥1 log10 IU/mL HBsAg decline from baseline during prior therapy.
- Discontinued ASO/siRNA therapy before screening.
- Screening HBsAg: 0.05-500 IU/mL.
- No prior interferon (IFN) therapy within 6 months before enrollment.
- Willingness to comply with study-related treatments, tests, and procedures.
- Commitment to contraception during the study.
- Voluntary participation with signed informed consent.
Exclusion
- Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology within 6 months before/during screening).
- Elevated AFP: Screening AFP \>100 ng/mL; AFP 20-100 ng/mL with imaging-confirmed hepatocellular carcinoma (ultrasound/CT/MRI).
- Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV).
- Recent immunomodulatory therapy: Systemic corticosteroids, thymosin, or other potent immunomodulators for \>2 weeks within 6 months before enrollment.
- Pregnancy, lactation, or plans for pregnancy during the study.
- Autoimmune hepatitis.
- Active autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus).
- Uncontrolled cardiovascular disease (e.g., unstable angina, myocardial infarction within 6 months).
- Poorly controlled endocrine disorders (e.g., diabetes mellitus, thyroid dysfunction).
- Severe psychiatric disorders: History of depression, anxiety, bipolar disorder, schizophrenia, or family history of psychiatric conditions (especially depression).
- Substance abuse: Alcohol (\>40 g/day for males; \>20 g/day for females) or Illicit drug use.
- Severe retinopathy or ophthalmologic disorders.
- Renal diseases: Chronic nephritis, renal insufficiency, nephrotic syndrome.
- Major organ dysfunction (e.g., heart, lung, pancreas).
- Organ transplant recipients or candidates.
- Hypersensitivity to interferon or excipients.
- Concurrent participation in other HBV-related interventional trials.
- Other conditions deemed unsuitable by investigators (e.g., non-compliance risk).
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06923280
Start Date
May 1 2025
End Date
May 31 2028
Last Update
April 11 2025
Active Locations (1)
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1
Huashan Hospita
Shanghai, China, China