Status:
COMPLETED
Single Center Pilot Study of Corticosteroid Discontinuation in Liver Transplant Recipients
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and myco...
Detailed Description
To determine the safety and efficacy of early corticosteroid discontinuation in liver transplant recipients more than 90 days post transplant, utilizing a combination of two drugs (tacrolimus and myco...
Eligibility Criteria
Inclusion
- Greater than 90 days post transplant.
- Free from rejection within the last 30 days.
- Patient with primary diagnosis of AIH will be evaluated on an individual basis.
- Negative pregnancy test.
- Practicing an acceptable method of birth control.
- Capable of providing written informed consent.
Exclusion
- Rejection within the last 30 days.
- Patients with AIH unable to discontinue corticosteroids.
- Patients currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation is contraindicated.
- Known sensitivity or contraindication to tacrolimus or MMF.
- Kidney, pancreas, islet, heart, lung, or small bowel transplant recipient.
- Pregnant or lactating.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00374231
Start Date
October 1 2002
End Date
January 1 2008
Last Update
December 29 2015
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45267