Tests interferon after stopping RNA-targeted hepatitis B treatment
Tests peginterferon alfa in adults with chronic hepatitis B after RNA-targeted treatment ends.
Plain-language title generated from the registry record
Registry title: Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens
Key facts
- Where
- Beijing and Shanghai, ChinaSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT06923280, who can take part
Where in China
- Beijing Ditan HospitalBeijing, ChinaTaking people
- Huashan HospitaShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT06923280
- Record updated
- 29 July 2026
- Original description
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:Read full original descriptionShow less
Efficacy and Safety of Pegylated Interferon Therapy in Chronic Hepatitis B Patients After Discontinuation of Antisense Oligonucleotide or Small Interfering RNA: A Prospective, Adaptive, Open-label, Randomized Controlled Study
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).
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: 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: Decompensated cirrhosis or hepatic malignancy (evidenced by imaging or histology within 6 months before/during screening); Recent immunomodulatory therapy: Systemic corticosteroids, thymosin, or other potent immunomodulators for >2 weeks within 6 months before enrollment; Substance abuse: Alcohol (>40 g/day for males; >20 g/day for females) or Illicit drug use; Organ transplant recipients or candidates; Concurrent participation in other HBV-related interventional trials; Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV); 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); Severe retinopathy or ophthalmologic disorders; Renal diseases: Chronic nephritis, renal insufficiency, nephrotic syndrome; Major organ dysfunction (e.g., heart, lung, pancreas); Hypersensitivity to interferon or excipients; Other conditions deemed unsuitable by investigators (e.g., non-compliance risk); Elevated AFP: Screening AFP >100 ng/mL; AFP 20-100 ng/mL with imaging-confirmed hepatocellular carcinoma (ultrasound/CT/MRI); Pregnancy, lactation, or plans for pregnancy during the study.