Clinical trial

Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation

Name

2023DZX32

Description

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.

Trial arms

Trial start

2023-12-01

Estimated PCD

2026-12-01

Trial end

2028-12-01

Status

Not yet recruiting

Treatment

Tacrolimus or Cyclosporine A

The 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.

Arms:

immunosuppressive withdrawal

Other names:

immunosuppression withdrawal

Size

Primary endpoint

Number of immune tolerance participants

Enrollment to 2 year post cessation of immunosuppression

Eligibility criteria

Inclusion Criteria: * 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) * Liver biopsy: No signs of acute rejection or chronic rejection, and no obvious fibrosis (Ishak\<2) 2 years before enrollment * Female recipients of fertility treatment must have a negative pregnancy test before enrollment * No Hepatitis virus infection 1 year before enrollment * Written consents are required Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 47, 'type': 'ESTIMATED'}}

Updated at

2023-11-27

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication