Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation
Start Date
5/14/2026
Completion Date
10/1/2031
Summary
This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps. Liver tests will be checked every 0.5 months through month 4, once a month through month 12, and every other month through month 18. Liver transplant (LTx) center visits will take place at screening, months 6, 12 and 18 after initiating IS dose reduction. A protocol driven liver biopsy to adjudicate the endpoint will be performed at 18 months. The duration of the study from time of starting IS dose reduction to the primary endpoint assessment is 18 months. The primary objective is to assess the efficacy of 50 percent IS dose reduction in children with Liver transplants (LTxs)
Eligibility Criteria
Age Range: 3 years to 13 years
Interventions
Tacrolimus reduction
Conditions
Locations
UCSF Benioff Children's Hospital
San Francisco, California 94143
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
Emory University School of Medicine/Children's Healthcare of Atlanta
Atlanta, Georgia 30307
United States
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Columbia University Medical Center
New York, New York 10032
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 15224
United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
United States