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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis B who took part in earlier ASO or siRNA trials and stopped that treatment. They will receive PEG-IFNα.
- Age
- 18 Years to 80 Years
- Sex
- All
- Disease stage
- Chronic hepatitis B (HBsAg positive for more than 6 months). HBsAg level at screening between 1 and 500 IU/mL.
- Earlier treatment
- Must have received at least 1 dose of ASO/siRNA (or placebo) in an earlier trial, with an HBsAg drop of at least 1 log10 IU/mL, and have stopped it before screening. No interferon within 6 months before enrollment.
- Biomarker or test result
- HBsAg between 1 and 500 IU/mL at screening.
Main reasons for not taking part
- Decompensated cirrhosis or liver cancer
- Co-infection with hepatitis A, C, D, E or HIV
- Pregnancy, breastfeeding or plans for pregnancy
- Autoimmune hepatitis or active autoimmune disease
- Severe psychiatric disorder, or alcohol or drug abuse
Read by machine on 9 November 2026.
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial 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.