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Can a new combo wipe out hepatitis b for good?
NCT ID NCT07537387
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether a medicine called peginterferon alfa, alone or with other antivirals, can clear the hepatitis B surface antigen from the blood. A total of 10,000 adults aged 18-65 who have used interferon before and still have low antigen levels will take the treatment for 48 weeks. The goal is to see if this leads to a functional cure, meaning the virus is no longer detectable.
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.
- Participants
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About 10,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
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.
Who is studied
Chronic hepatitis B patients who received pegylated interferon alpha for the first time and achieved a good response.
- Ages
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18 to 65 years
- Sex
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Anyone
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: * • Voluntary participation and ability to understand and provide written informed consent. * Age 18-65 years (inclusive), either gender. * Documented HBsAg positivity for at least 6 months, or other evidence confirming chronic hepatitis B (CHB). * Prior interferon therapy before enrollment (treatment discontinuation ≥ 3 months), with HBsAg level at the end of prior treatment reduced by ≥ 50% from baseline. * HBsAg ≤ 500 IU/mL at screening, and HBsAg rebound at screening not exceeding 50% of the baseline HBsAg level during the first-round interferon therapy. * Negative pregnancy test within 24 hours prior to the first dose (for women of childbearing potential); all subjects (male and female) must use effective contraceptive measures during the study. Exclusion Criteria: * • Pregnant or lactating women, or subjects with a pregnancy plan during the study period. * Subjects with neuropsychiatric disorders, in particular a history of depression, anxiety, mania, schizophrenia, or a family history of psychiatric disorders (especially a history of depression or depressive tendency). * Concurrent active infection with hepatitis A, hepatitis C, hepatitis E and/or HIV, or chronic liver disease due to other causes (e.g., alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, etc.). * Evidence of acute severe liver damage: e.g., ALT \> 10 × ULN, or marked ALT elevation accompanied by significant hyperbilirubinemia. * Evidence of decompensated liver disease: e.g., ascites, esophagogastric variceal bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or prior evidence of decompensated cirrhosis. * Evidence of hepatocellular carcinoma (HCC), or AFP \> 1 × ULN. * Renal diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or serum creatinine \> 1 × ULN at screening. * Neutrophil count \< 1.5 × 10⁹/L, platelet count \< 90 × 10⁹/L, or serum phosphorus \< 0.8 mmol/L during the screening period. * Autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus, etc.), endocrine disorders (e.g., thyroid diseases, diabetes, etc.), hypertension poorly controlled by prescription medications (blood pressure ≥ 140/90 mmHg), a history of severe heart disease (especially poorly controlled within 6 months), severe retinopathy or other serious ophthalmologic diseases, or other organic lesions or dysfunction of vital organs. * Subjects planning to undergo or having previously undergone organ transplantation. * Subjects with hypersensitivity to the investigational product or its excipients, or meeting any contraindication listed in the prescribing information of the investigational product. * Other conditions deemed inappropriate for enrollment by the investigator
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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
1 site. 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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Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
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