Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver … (NCT01481974) | Clinical Trial Compass
CompletedPhase 1
Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation
United States35 participantsStarted 2012-12
Plain-language summary
The overall purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of a five-days post-operative course of Treprostinil in liver transplant patients.
The hypothesis of this study is that Treprostinil can be safely administered post-operatively in liver transplant patients. Once safety is documented future studies will address its ability to ameliorate or prevent reperfusion mediated dysfunction of the liver graft and thereby reduce morbidity, leading to shorter hospital stays as compared to historical controls.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Have signed appropriate informed consent.
✓. Be between 18 years and 65 years of age.
✓. Have been accepted as a liver transplant candidate at the University of Pittsburgh Medical center (UPMC).
✓. Be receiving a cadaver donor liver transplant.
✓. Be treated in accordance with the standard of care protocol(s) currently in effect for liver transplant recipients at the UPMC, including immunosuppression and other elements of pre- and post-operative care.
Exclusion criteria
✕. Be receiving a living donor liver transplant.
✕. Be receiving a donor liver with a cold ischemia time less than 5 hours or greater than 12 hours.
✕. Be receiving any investigational drug (a drug other than Treprostinil administered under an IND) or participating in any other investigational study, with the exception of alemtuzumab (Campath).
✕. Be receiving any prostanoid to treat portopulmonary hypertension.
What they're measuring
1
Serum ALT concentration after treprostinil treatment in liver transplant patients