Status:
COMPLETED
Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation
Lead Sponsor:
Abhinav Humar, MD
Conditions:
Ischemia Reperfusion Injury
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 hypothesi...
Detailed Description
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 mini...
Eligibility Criteria
Inclusion
- 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
- Subjects must not:
- 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.
- Have had a failed liver transplant within the previous 180 days.
- Be undergoing multi-organ transplantation (transplantation of organs other than liver at the same time as the liver transplantation procedure).
- Have fulminant hepatic failure
- Model for end stage liver diseases (MELD) score of \> 40
- Hepatitis C positive donor liver
- On renal replacement therapy at the time of study
- Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results.
- Those currently receiving treatment for portopulmonary hypertension.
- Those with significant cardiovascular disease including treatment with inotropes.
- Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil.
- If female, be pregnant or nursing (as confirmed by urine pregnancy test at Baseline).
- HIV positive
- Individuals who are allergic to iodine
- Individuals who are receiving methylene blue
- A donor liver with macrosteatosis greater than 40% if biopsy results are available
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01481974
Start Date
December 1 2012
End Date
November 24 2019
Last Update
December 15 2023
Active Locations (2)
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1
Abhinav Humar
Pittsburgh, Pennsylvania, United States, 15261
2
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261