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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Tacrolimus or Cyclosporine A
DrugThe protocol of IS withdrawal:Week 1-4 take Tacrolimus (Tac) or Cyclosporine A (CsA) once daily for weeks. Week 5-8 medication reduction to taking Tac / CsA 4 times a week . Week 9-12 reduction to taking Tac/ CsA 3 times a week. Week 13-18 reduction to taking Tac / CsA 2 times a week . Week 19-24 reduction to taking Tac/ CsA once per week. Week 25, the recipients will stop taking Tac/ CsA.
Treatment groups
47 Participants
are divided into 1 treatment groupGroup A: immunosuppressive withdrawalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of immune tolerance participants
Number of participants who are immune tolerance, defined as those who successfully withdraw from immunosuppression and maintain normal graft status as assessed by liver biopsy and liver tests 2 years after complete immunosuppression withdrawal.
Time frame
Enrollment to 2 year post cessation of immunosuppressionSecondary outcomes
1
Number of participants with complications attributed to immunosuppression withdrawal
This endpoint is comprised of complications related to immunosuppression withdrawal and is defined as the occurrence of any of the following: death or graft loss, histologic evidence of refractory acute rejection or biopsy confirmed chronic rejection.
Time frame
Enrollment to 4 year post cessation of immunosuppression2
Impact of iImmunosuppression withdrawal on graft histology
Histologic progression determined from the stage of fibrosis at baseline to completion of the study according to the Ishak Severity System
Time frame
Enrollment to 4 year post cessation of immunosuppression3
Severity of acute rejection in immunotolerant recipients
Acute rejection severity (mild, moderate, severe) is based on the Banff global assessment grade according to the central pathology reading of the liver biopsy.
Time frame
Enrollment to 2 year post cessation of immunosuppressionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Wei Gao
Lead sponsor
Tianjin First Central Hospital
Sponsor institution
Source ClinicalTrials.gov
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