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Could a drug combo cure hepatitis b in kids? new trial aims to find out

NCT ID NCT07345624

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether giving two antiviral drugs—entecavir followed by pegylated interferon—can help children aged 3 to 6 with chronic hepatitis B achieve a functional cure (clearing the virus from the blood). About 80 children will be randomly assigned to receive either entecavir alone or entecavir plus the second drug. The goal is to see if the combination leads to better long-term virus control and possible cure, though lifelong monitoring may still be needed.

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 80 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. Aged 3-6 (more than 3 but less than 7) years; 2. With chronic HBV infection; 3. HBeAg-positive; 4. HBV DNA \>1.0×10⁷ IU/mL; 5. Normal upper abdominal ultrasound; 6. ALT \<40 U/L, HBsAg positivity, HBeAg positivity, and HBV DNA\>1.0×10⁷IU/mL for at least two times, with an interval of 6 months or more. 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

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  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.