Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation

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)

NCT Number	NCT07549503
Lead Sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Conditions	Liver Transplant
Enrollment	100 participants
Start Date	2026-05-14
Primary Completion	2031-04-01 (estimated)
Study Completion	2031-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-09