Pegylated Interferon-alpha (IFN): pegylated interferon-alpha 180 μg once weekly for 24 weeks
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.
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).
Primary outcome measure(s)
HBV DNA and HBsAg undetectable with/without anti-HBs — week 72 Proportion of patients achieving HBV DNA below the lower limit of quantification (LLOQ; \<20 IU/mL), HBsAg undetectable (\<0.05 IU/mL) (with or without anti-HBs seroconversion), and normal liver biochemical indices at Week 72.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.