Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens
Recruiting · NCT06923280 · Interventional (participants receive a specific treatment) · Lead sponsor: Huashan Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Inclusion criteria
- 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: 1-500 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 criteria
- 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).
Where it is running
2 locations listed.
- Beijing Ditan Hospital - Beijing, China, China
- Huashan Hospita - Shanghai, China, China