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New hope for kids with hepatitis b: drug combo aims for cure

NCT ID NCT07345611

Disease control Sponsor: Qing-Lei Zeng Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding pegylated interferon to entecavir helps young children (ages 3-6) with chronic hepatitis B achieve a functional cure, meaning the virus becomes undetectable. Sixty children will receive either entecavir alone or entecavir followed by the combination. The goal is to see if the combo leads to better long-term control of the infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
entecavir and pegylated interferon α-2b
What this could lead to
If successful, this could offer a way to achieve functional cure in young children with chronic hepatitis B, potentially reducing long-term liver damage.
What could go wrong
This is a small, early-phase trial with only 60 children, and the combination therapy may cause more side effects. Functional cure is not guaranteed, and long-term benefits remain uncertain.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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

3 to 6 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. Age between 3 and 6 (more than 3 but less than 7) years; 2. Chronic HBV infection; 3. Positive HBeAg; 4. HBV DNA \>1.0×10⁴ IU/mL; 5. Normal upper abdominal ultrasound without cirrhosis or hepatocellular carcinoma; 6. ALT \>40 U/L. Exclusion Criteria: 1. Previous antiviral treatment for chronic HBV infection; 2. Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus; 3. Previous or current evidence of hepatocellular carcinoma or cirrhosis; 4. Coexistence of any other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease; 5. Coexistence of systemic/other organ disorders (for example with evidence of thyroid disorders); 6. Hemoglobin level \<100 g/L; 7. Absolute neutrophil count \<1.0×10⁹/L.; 8. Platelet count \<125×10⁹/L; 9. Total bilirubin \>1 ULN, i.e., 17.1 μmol/L; 10. Albumin level \<35 g/L; 11. Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, Chinese traditional medicine or supplements, nonsteroidal anti-inflammatory drugs, or steroids.

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Children Chronic hepatitis B Hepatitis B virus infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.