A second punch against hepatitis b: interferon after RNA drugs may clear the virus
NCT ID NCT06923280
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This trial tests whether giving pegylated interferon to people with chronic hepatitis B—after they have already received an antisense oligonucleotide or small interfering RNA treatment—can clear the hepatitis B surface antigen from their blood. About 72 adults who saw a significant drop in that antigen during prior therapy will be randomly assigned to start interferon right away or wait 24 weeks. The goal is to see if this sequential approach leads to a functional cure, where the virus stays undetectable even after treatment stops.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pegylated interferon-alpha
- What this could lead to
- If successful, this approach could help more people with chronic hepatitis B achieve a functional cure—clearing the virus from their blood without lifelong medication.
- What could go wrong
- This is an early-stage trial with only 72 participants, and interferon therapy can cause flu-like symptoms, fatigue, and mood changes. The results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Ditan Hospital
RECRUITINGBeijing, China, China
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Huashan Hospita
RECRUITINGShanghai, China, China
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