Safety and Efficacy of Perioperative Remodulin® in Orthotopic Liver Transplant Recipients

• Status: Withdrawn
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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 minor abnormalities to primary nonfunction. Prostaglandin-class drugs, including prostacyclin and its analogs, could represent an important advance toward the goal of reducing transplant related morbidity, mortality and associated costs by providing these benefits.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Therapeutics
• Collaborator: University of Pittsburgh
• Treatments: Treprostinil

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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