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New hope for kids with hepatitis b: interferon trial aims for functional cure

NCT ID NCT07231276

Disease control Sponsor: Nanfang Hospital, Southern Medical University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a weekly injection of pegylated interferon alfa-2b for 48 weeks can help children and teens (ages 3–17) with chronic hepatitis B achieve a functional cure. The treatment group will be compared to an observation group receiving no drug or standard antivirals. The goal is to see if the drug can clear the virus and improve immune responses, potentially leading to better long-term outcomes.

What this could mean

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

Active substance
pegylated interferon alfa-2b
What this could lead to
If successful, this could point toward a functional cure for chronic hepatitis B in children and teens, reducing their lifelong infection risk.
What could go wrong
This is a phase 4 study with only 113 participants, so results may not apply to everyone. Interferon can cause flu-like symptoms and other side effects, and a functional cure is not guaranteed.

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 113 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

Oct 2028

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 18 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: * Aged 3 years and above but under 18 years; * Positive for hepatitis B virus (HBV) DNA; * Positive for hepatitis B surface antigen (HBsAg) (above the lower limit of baseline detection or \> 0.05 IU/ml); * The subject and their guardian(s) understand the study and voluntarily sign the informed consent form (if the guardians are the subject's parents, both parents must sign jointly). Exclusion Criteria: * Co-infection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV); * Having contraindications to pegylated interferon alfa-2b: 1. Decompensated hepatitis B cirrhosis; 2. Subjects with autoimmune liver disease, metabolic liver disease, alcoholic liver disease, malignant tumor, decompensated liver disease, or a history of organ transplantation; 3. Subjects with severe neurological or psychiatric diseases; 4. Subjects with severe thyroid dysfunction, antinuclear antibody hyperactivity, or other autoimmune diseases; 5. Subjects with diabetes mellitus with poor blood glucose control; 6. Subjects with retinal or fundus lesions; 7. Subjects with severe heart disease, coronary heart disease, or cerebrovascular disease; 8. Subjects with poorly controlled epilepsy; * Adolescent and pediatric subjects with severe renal dysfunction (e.g., creatinine \> 1.5 × upper limit of normal \[ULN\]); * Subjects deemed unsuitable for enrollment by the investigator(s).

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Conditions

The condition(s) this trial relates to.

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.

Chronic hepatitis B virus HBV

How to take part

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

  1. The places running it

    1 site. 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

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515, China

More trials for these conditions

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