Status:
COMPLETED
A Study of a Modified-Release Tacrolimus Based Immunosuppression Regimen in Stable Pediatric Liver Transplant Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE2
Brief Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable pediatric liver transplant patients converted from a Prograf® based immunosuppression regimen to a modified rel...
Detailed Description
A 1 arm study to assess the pharmacokinetics, and long-term safety and effectiveness of a modified release tacrolimus based immunosuppression regimen in stable pediatric liver transplant patients conv...
Eligibility Criteria
Inclusion
- Patient is currently receiving Prograf® based immunosuppressive therapy for liver transplantation.
- Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable
Exclusion
- Patient has previously received an organ transplant other than a liver
- Patient is currently receiving sirolimus immunosuppression therapy.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00282256
Start Date
January 1 2004
End Date
October 1 2008
Last Update
October 17 2013
Active Locations (5)
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1
Atlanta, Georgia, United States, 30322
2
Indianapolis, Indiana, United States, 46202
3
New Orleans, Louisiana, United States, 70433
4
New York, New York, United States, 10029