NCT06923280Recruiting

Sequential PEG-IFN for HBV After Ending RNA-targeted Regimens

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

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

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).

Status (registry): Recruiting
Study type: Interventional
Enrollment: 72 (estimated)
First submitted: 3 Apr 2025
Start date: 25 Aug 2025
Primary completion date: 31 Dec 2027
Lead sponsor: Huashan Hospital
Diseases: Hepatitis B
NCT number: NCT06923280

What you commit to

Study type: Interventional
Planned participants: 72
From 25 Aug 2025 to the primary completion date, 31 Dec 2027
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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.

Other illness

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).

Other

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.

Who the study is looking for

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.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Beijing Ditan Hospital Coordinator of this site? Confirm its status	Beijing	China	Recruiting
Huashan Hospita Coordinator of this site? Confirm its status	Shanghai	China	Recruiting

Related publications

Efficacy and Safety of Pegylated Interferon as Rescue Therapy for Patients with Chronic Hepatitis B Who Failed to Achieve Functional Cure After Antisense Oligonucleotides or Small Interfering RNA: A Prospective, Multicentre, Open-Label Randomized Controlled Trial (SPHERE) Protocol.Adv Ther · 2026 · PMID 42176181

This page is information, not medical advice. Discuss any trial with your doctor.