Can a Two-Drug combo clear hepatitis b for good?
NCT ID NCT05490836
First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time
Summary
Researchers are testing whether peginterferon alfa-2b injections plus tenofovir alafenamide pills can help adults with HBeAg-negative chronic hepatitis B clear the virus. The trial enrolls 210 previously untreated patients and compares continuous treatment with a pulsed schedule over 48 weeks. The main goal is to see how many participants lose hepatitis B surface antigen, a marker of functional cure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Peginterferon alfa-2b combined with tenofovir alafenamide
- What this could lead to
- If it works, this could offer a path to a functional cure for chronic hepatitis B, letting people stop daily antiviral pills and reducing liver damage risk.
- What could go wrong
- This is a mid-stage trial, and interferon shots can cause flu-like symptoms, fatigue, and mood changes. Many patients do not clear the virus, and the pulse schedule may prove less effective than continuous treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
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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210 people
The number who actually took part.
- Started
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Sep 2022
- Finished
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Sep 2026
- 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 65 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: * Aged between 18 and 65,included. * HBsAg positive, HBeAg negative, anti HBE antibody positive, HBV-DNA ≥ 2x10\^3 IU/ml, ALT is continuously or repeatedly abnormal, or there is definite inflammation, necrosis and / or fibrosis (≥ G2/S2) confirmed in liver biopsy. * Received no antiviral treatment previously. * pregnancy test of Female subjects of childbearing must be negative before the enrollment, and all potential subjects must agree to take effective contraceptive measures during the treatment period and within half a year after the end of the treatment. * Understand and sign the informed consent voluntarily. Exclusion criteria: * Known allergy to interferon, nucleos(t)ide drugs, or any ingredient of the drug. * Currently co-infection with HAV, HCV, HDV, HEV, HIV, or any other virus. * Cirrhosis or Child-Pugh score of 7 or above. * Liver disease caused by other reasons (eg. autoimmune liver disease, alcoholic liver disease, nonalcoholic fatty liver disease, drug-induced hepatitis, hepatolenticular degeneration, etc.). * Pregnant or lactating women. * Alcoholism or drug abuse within one year prior to the screening. * Neutrophil count\<1.5×10\^9/L, hemoglobin\<100g/L, or platelet count\<80×10\^9/L. * Serum creatinine was higher than the upper limit of normal at screening. * History of serious disease in heart, brain, kidney, retina, muscle, or other major organ and systems. * Have a history of mental illness or family history of mental illness, or Hamilton Depression Scale score ≥ 7 points. * Have a history of endocrine system or autoimmune diseases, such as thyroid disease, systemic lupus erythematosus, sarcoidosis, autoimmune thrombocytopenic purpura, psoriasis, etc. * Chronic diseases requiring long-term treatment, such as uncontrolled hypertension, diabetes, chronic obstructive pulmonary disease, etc. * Malignant tumor. * Suspected hepatocellular carcinoma in B-ultrasound at screening; or fetoprotein alpha was greater than 100ng/ml, or cannot remain stable within 3 months before screening. * Accepted organ transplantation previously. * Other reasons that the investigator considers unsuitable for inclusion.
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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.
Contacts and locations
Locations
-
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200081, China
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Other studies related to the condition(s) this trial covers.
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