Evaluating the Effects of Reducing Immunosuppressive Medicine by Half in Children Aged 3-13 With Liver Transplants

What this Trial Is About

Researchers are investigating the effects of reducing immunosuppressive medicine by 50 percent in children who have undergone liver transplants. This phase 2, multi-center, prospective study aims to assess whether lowering immunosuppression can be done successfully without causing rejection. The study focuses on children between 3 and 13 years old who received their liver transplant before age 7 and are currently stable without recent rejection episodes. Participants will reduce their tacrolimus immunosuppressive medication in two steps first lowering the dose to 75 percent of the original amount for six weeks, then reducing it further to 50 percent. For those taking tacrolimus twice daily, the evening dose is adjusted accordingly. Liver tests will be monitored frequentlyevery two weeks up to month 4, monthly through month 12, and every other month until month 18. Liver transplant center visits occur at screening and at months 6, 12, and 18, including a liver biopsy at 18 months to evaluate the primary outcome. Throughout the 18-month study period, participants will undergo regular blood tests to check liver function and ensure safety. Researchers will measure the success of immunosuppression reduction by monitoring for signs of acute rejection, both clinically and through biopsy. The study includes assessments of rejection severity and overall liver health. This detailed monitoring helps determine the viability of lowering immunosuppressive drugs in this pediatric population while safeguarding transplant function.

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