Status:
COMPLETED
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a modified ...
Detailed Description
A one arm study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable liver transplant patients converted from a tacrolimus (Prograf®) based immunosuppression regimen to a m...
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 :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00282243
Start Date
February 1 2003
End Date
October 1 2008
Last Update
September 30 2013
Active Locations (10)
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1
Palo Alto, California, United States
2
Denver, Colorado, United States, 80262
3
Baltimore, Maryland, United States, 21287
4
Ann Arbor, Michigan, United States, 48109