Sequential PEG-IFN for Hepatitis B After RNA-targeted Therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares two sequential pegylated interferon-alpha strategies in adults with chronic hepatitis B who previously received ASO or siRNA treatment. In phase 1, Group A receives 24 weeks of PEG-IFNα followed by 24 weeks off therapy, while Group B delays PEG-IFNα for 24 weeks and then receives 24 weeks of treatment; the goal is to see if sequencing improves HBsAg clearance and reduces relapse. The study will also describe response rates among non-responders and relapse rates among responders. Key eligibility requires prior ASO/siRNA exposure with at least a 1 log10 IU/mL HBsAg decline, and no interferon in the prior 6 months. Exclusions include decompensated liver disease, active hepatic cancer, and certain co-infections.

Why it matters

Who can join: the full rules

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's running

• Beijing Ditan Hospital
  Beijing, China, China Recruiting
• Huashan Hospita
  Shanghai, China, China Recruiting

Study contacts

• Principal investigator: Wenghong Zhang, MD — Huashan Hospital
• Study coordinator: Wenghong Zhang, MD
• Email: zhangwenhong@fudan.edu.cn
• Phone: 13801844344

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.