Can a Two-Drug combo wipe out hepatitis b for good?
NCT ID NCT07809165
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing whether adding a PD-1 antibody and pegylated interferon to standard antiviral pills can help people with chronic hepatitis B lose the hepatitis B surface antigen. The trial enrolls adults whose virus is already suppressed by nucleos(t)ide analogues and who have low levels of surface antigen. Participants receive sintilimab infusions plus weekly interferon injections while continuing their usual antiviral medication. The goal is to see if this sequential approach is safe and can lead to a 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
- a combination of sintilimab, an PD-1 antibody, and pegylated interferon-alpha 2b
- What this could lead to
- If the strategy works, it could offer a path to stopping daily antiviral pills and achieving a functional cure for chronic hepatitis B.
- What could go wrong
- The trial is small and early, and immune-based treatments can cause serious side effects or fail to clear the virus in most people.
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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 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 55 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: * 1\. Aged 18-55 years; * 2.Chronic hepatitis B patients with clear diagnosis of hematology, etiology and clinical (for example: HBsAg positive for more than 6 months); * 3\. Treatment with NAs(ETV, TDF or TAF)at least 1 years and continue NAs therapy during screening; * 4.Patients with HBV DNA negative, HBeAg negative, HBsAg quantification ≤ 500IU/ml . Exclusion Criteria: * 1\. Cirrhosis; * 2.platelet count \< 90×10\^9/L, WBC count \< 3.0×10\^9/L, ALT /AST\> ULN (40U/L), total bilirubin \> 2ULN; * 3.History of or suspicion of hepatocellular carcinoma * 4.Patients received interferon therapy within 6 months; * 5.Patients received immunosuppressive therapy or other therapy influenced study within 6 months; * 6.Pregnancy * 7.Hepatitis A, hepatitis C, hepatitis D, HIV infection or other active infections; * 8.Presence of severe uncontrolled diseases of respiratory, cardiovascular or other organ systems; * 9.Alcohol or drug abuse/dependence; * 10.Other conditions rendering subjects ineligible for enrollment, including but not limited to absolute contraindications to interferon therapy, known hypersensitivity to any study drug or their excipients, and anticipated poor compliance with treatment and follow-up procedures.
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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
4 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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Shandong Public Health Clinical Center
Jinan, China
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
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The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
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The Third People's Hospital of Taiyuan
Taiyuan, China
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