Reducing Immunosuppression by 50% in Young Liver Transplant Recipients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, longitudinal study enrolling children who are 3 to less than 7 years post liver transplant. The trial reduces immunosuppression by 50% in two steps and monitors liver tests frequently over 18 months. Endpoints include liver biopsy at 18 months to determine the effect on graft health, with regular clinic visits and labs to track safety and efficacy. The study aims to identify whether a substantial reduction in immunosuppression can maintain graft function without increasing rejection risk.

Why it matters

Who can join: the full rules

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

Where it's running

• UCSF Benioff Children's Hospital
  San Francisco, California, United States Recruiting
• MedStar Georgetown University Hospital
  Washington D.C., District of Columbia, United States Recruiting
• Ann and Robert H. Lurie Children's Hospital of Chicago
  Chicago, Illinois, United States Recruiting
• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting
• Columbia University Medical Center
  New York, New York, United States Recruiting
• Cincinnati Children's Hospital Medical Center
  Cincinnati, Ohio, United States Recruiting

Study contacts

• Study coordinator: Ada Chao
• Email: ada.chao@ucsf.edu
• Phone: 415-353-7004

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.