Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4+
SponsorWei Gao
About this trial
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.
Eligibility criteria
Qualifiers
Age at liver transplantation: under 6 years
Follow-up time after liver transplantation: more than 4 years
Liver function maintains normal before enrollment
Monotherapy of IS (Tacrolimus or Cyclosporine A)
Disqualifiers
Original disease before liver transplantation: Tumor, secondary liver transplantation, hepatitis virus infection, autoimmune hepatitis
Type of liver transplantation: ABO incompatible liver transplantation or multiple organ transplantation
Liver biopsy: obvious fibrosis(Ishak≥2；LAFSc moderate or severe)
Recipients taking IS for other diseases besides their liver transplantation
Trial design
Treatments tested in this trial
- Tacrolimus or Cyclosporine A
Treatment groups
47 Participants
are divided into 1 treatment groupSponsors and collaborators
Wei Gao
Lead sponsor
Tianjin First Central Hospital
Sponsor institution
Source ClinicalTrials.gov