Status:
TERMINATED
A Pilot Trial of Pediatric Liver Transplantation Without Steroids
Lead Sponsor:
Birmingham Women's and Children's NHS Foundation Trust
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Evidence of Liver Transplantation
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
Brief 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 ...
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 ster...
Eligibility Criteria
Inclusion
- Children undergoing primary isolated hepatic transplantation.
- Age \<=18 years
- Ability to provide informed consent
Exclusion
- Children undergoing retransplantation.
- Transplantation for Intestinal failure associated liver disease.
- Multi-organ transplantation.
- Transplantation for autoimmune liver disease.
- Transplantation for extra hepatic malignancy.
- Pre-existing need for oral steroids, or high dose inhaled steroids sufficient to require a steroid warning card.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00694408
Start Date
June 1 2008
End Date
August 1 2011
Last Update
January 20 2017
Active Locations (1)
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1
Birmingham Children's Hospital
Birmingham, West Midlands, United Kingdom, B4 6NH