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Liver transplant kids test cutting meds in half

NCT ID NCT07549503

Disease control Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 2 times

Summary

This study looks at whether children who received a liver transplant before age 7 can safely cut their anti-rejection drugs by 50%. One hundred kids will slowly reduce their medication over 18 months, with frequent blood tests and liver biopsies to check for rejection. The goal is to see if lower doses can keep the liver healthy while reducing side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

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

Started

May 2026

Expected to finish

Oct 2031

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 13 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. Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively 2. Recipient of a living or deceased donor Liver transplant (LTx) at \<7 years of age 3. \> 3 years but \<7 years after LTx at the time of study enrollment 4. Stable liver tests defined as baseline serum alanine aminotransferase (ALT) level \< 30 IU/l and gamma-glutamyl transferase (GGT) level \< 50 IU/l (based on the average of the 3 most recent values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening) 5. No Acute rejection (AR) or chronic rejection within 12 months of enrollment 6. Tacrolimus monotherapy for \> 6 months with baseline 12-hour trough levels \<8 ng/mL (based on the average of 3 values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening) 7. Participants of childbearing potential must have a negative pregnancy test upon study entry Exclusion Criteria: 1. Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis 2. LTx for hepatitis B or hepatitis C 3. Recipient of any other organ transplant or liver re-transplant, except for patients who have a repeat LTx within 30 days of first LTx who are eligible for enrollment 4. \>=50 percent dose increase in tacrolimus within 12 months of enrollment 5. Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment 6. Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced 7. Use of medication to treat systemic conditions which in the judgement of the investigator could influence results of the study 8. Active or chronic infection requiring treatment 9. Inability or unwillingness to comply with the study protocol 10. Use of investigational drug within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of enrollment 11. Has any condition that, in the opinion of the investigator, will interfere with safe participation in the trial

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As listed by the trial registrant

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

Liver transplant

How to take part

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

  1. The places running it

    10 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

  • Ann and Robert H. Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Children's Hospital Colorado

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital of Philadelphia

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 15224, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Emory University School of Medicine/Children's Healthcare of Atlanta

    NOT_YET_RECRUITING

    Atlanta, Georgia, 30307, United States

  • Icahn School of Medicine at Mount Sinai

    NOT_YET_RECRUITING

    New York, New York, 10029, United States

  • MedStar Georgetown University Hospital

    NOT_YET_RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Monroe Carell Jr. Children's Hospital at Vanderbilt

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

  • UCSF Benioff Children's Hospital

    RECRUITING

    San Francisco, California, 94143, United States

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