drugset / Trial / NCT06147375

Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation

NCT06147375

Not yet recruiting 47 enrolled Wei Gao
NaSingle-groupOpen-labelDiagnostic

Summary

The goal of this clinical trial is to learn about the efficacy and safety of immunosuppressive withdrawal in pediatric liver transplant recipients. The main question it aims to answer is:exploring the landscape of immune tolerance after pediatric liver transplantation. Moreover,this clinical trial aims to provide important foundation and clinical data for inducing immune tolerance, as well as to clarify the mechanism of immune tolerance development in pediatric liver transplantation, identify biomarkers that can be used to predict immune tolerance, and build a prediction model of immune tolerance after pediatric liver transplantation. The study planned to enroll 47 recipients after pediatric liver transplantation which would gradually withdrawal immunosuppressive after enrollment, divided the participants into immune tolerance and immune intolerance groups based on the outcome of immunosuppressive withdrawal.In this study, we collect the peripheral blood and liver biopsy samples from the two groups, find biomarkers with predictive value for immune tolerance in recipients after pediatric liver transplantation, and build a predictive model of immune tolerance by machine learning.

Timeline

Start
2023-12-01
Primary completion
2026-12
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclosporine Peptide
Subject Tacrolimus Small molecule

Indications

No indication recorded.