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A Pilot Trial of Pediatric Liver Transplantation Without Steroids

Evidence of Liver Transplantation Clinical Trial

Official title:
A Randomized Pilot Trial of a Steroid-free Immunosuppressant Regimen in Pediatric Liver Transplantation

Clinical Trial Summary

Objective:

The overall objective is to investigate whether a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation and whether it promotes tolerance.

Clinical Trial Description

3.2 Research question

Is it possible to avoid the use of corticosteroids in pediatric liver transplantation?

3.3 Trial objectives

This will be a pilot study to

i) investigate to what degree a steroid free immunosuppressive regimen is as safe and effective as a steroid containing regimen following pediatric liver transplantation

ii) investigate the effect of a steroid free immunosuppressive regimen on lymphocyte function and donor-specific immune responsiveness following pediatric liver transplantation

iii) investigate the effect of a steroid free immunosuppressive regimen on expression of tissue markers of tolerance following pediatric liver transplantation

It is hoped that this pilot study will be used to develop a definitive multicentre study of a steroid free regimen. ;

Study Design

Related Conditions & MeSH terms

  • Evidence of Liver Transplantation
Clinical Trial Details
NCT number NCT00694408
Study type Interventional
Source Birmingham Children's Hospital NHS Foundation Trust
Contact
Status Terminated
Phase Phase 3
Start date June 2008
Completion date August 2011
View Details
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