Can a Two-Drug combo wipe out hepatitis b for good?

NCT ID NCT07809165

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Shandong Public Health Clinical Center

    Jinan, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • The Third People's Hospital of Taiyuan

    Taiyuan, China

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