NCT00694408

A Pilot Trial of Pediatric Liver Transplantation Without Steroids

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Birmingham Women's and Children's NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Evidence of Liver Transplantation

Interventions

Type	Name	Description
DRUG	methyl prednisolone, hydrocortisone, prednisolone	Will be specific dependant on weight of patients
OTHER	No steroids	Children undergoing primary liver transplant will receive monoclonal antibodies and tacrolimus as per protocol

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2008-06-10
• Last updated: 2017-01-20

Locations

1 site across 1 country: United Kingdom