Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06147375
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-10-26
Brief Title:
Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
Sponsor:
Wei Gao
Organization:
Tianjin First Central Hospital
Study Overview
Official Title:
Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 isexploring the landscape of immune tolerance after pediatric liver transplantation Moreoverthis 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 withdrawalIn 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
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 withdrawalIn 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
Detailed Description:
Background The main conditions which require pediatric liver transplantation are benign diseases with curable primary diseases such as metabolic and biliary diseases After liver transplantation the two main risk factors affecting recipients survival are cumulative IS toxicity and chronic graft injuries Adverse reactions such as renal dysfunction metabolic problems infection and cancer can result from chronic exposure to IS As a result decreasing or stopping immunosuppressive treatment is an effective way for improving recipients survival after liver transplantation Currently the recipients after pediatric liver transplantation lacks defined IS withdrawal plans and also unified and uniform recipients selection criteria and processes Additionally IS withdrawal could result in graft fibrosis rejection and graft dysfunctionTherefore the safety and efficacy of IS withdrawal needs to be discussed
MethodsThe study planned to enroll 47 recipients after pediatric liver transplantation which would gradually withdrawal IS after enrollment divided the participants into immune tolerance and immune intolerance groups based on the outcome of IS withdrawalIn this study we will 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
Protocol after enrollment After enrollmentthe recipients will take IS withdrawal follow the protocol of this studyThe IS withdrawal protocol is once daily for weeks 1 to 4 then decreased every 4 weeks until the IS is totally stopped by 25 weeks Following enrollment recipients will be examined at several time periods such as peripheral blood testsliver function liver biopsy and other relevant indicators to determine IS withdrawal and adverse effects
MethodsThe study planned to enroll 47 recipients after pediatric liver transplantation which would gradually withdrawal IS after enrollment divided the participants into immune tolerance and immune intolerance groups based on the outcome of IS withdrawalIn this study we will 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
Protocol after enrollment After enrollmentthe recipients will take IS withdrawal follow the protocol of this studyThe IS withdrawal protocol is once daily for weeks 1 to 4 then decreased every 4 weeks until the IS is totally stopped by 25 weeks Following enrollment recipients will be examined at several time periods such as peripheral blood testsliver function liver biopsy and other relevant indicators to determine IS withdrawal and adverse effects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None