Status:
WITHDRAWN
Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients
Lead Sponsor:
United Therapeutics
Collaborating Sponsors:
University of Pittsburgh Medical Center
Conditions:
Liver Transplant
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
Brief Summary
Patients undergoing orthotopic liver transplant will experience some degree of clinical and/or biochemical hepatic dysfunction. This early injury is known as primary graft dysfunction and varies from ...
Detailed Description
In vitro and in vivo research has consistently demonstrated an array of potential beneficial effects of prostanoids under both immune and non-immune circumstances relevant to liver allografts. (1-3) R...
Eligibility Criteria
Inclusion
- Accepted as a liver transplant candidate at the University of Pittsburgh Medical Center
- Be receiving a cadaver donor liver transplant
- Treated in accordance with the standard of care protocol(s) in effect for liver transplant recipients at the University of Pittsburgh Medical Center.
Exclusion
- Receiving a living done liver transplant
- Receiving a donor liver with a cold ischemia time less that 6 hours
- Receiving a donor liver with macrosteatosis greater than 30%
- Receiving any investigation drug with the except of alemtuzamab (Camphath)
- Failed liver transplant in previous 180 days
- Prior organ transplant or cell infusion
- Undergoing multi-organ transplant
- Pregnant or nursing female
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01884038
Start Date
June 1 2008
End Date
June 1 2010
Last Update
December 19 2023
Active Locations (1)
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1
University of Pittsburgh Medical Center, Starzl Transplantation Institute
Pittsburgh, Pennsylvania, United States, 15213