Safety and Efficacy of Treprostinil in Ischemia and Reperfusion Injury in Adult Orthotopic Liver Transplantation

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abhinav Humar, MD; University of Pittsburgh
• Treatments: Treprostinil

Criteria

Inclusion Criteria:

1. Have signed appropriate informed consent.

2. Be between 18 years and 65 years of age.

3. Have been accepted as a liver transplant candidate at the University of Pittsburgh Medical center (UPMC).

4. Be receiving a cadaver donor liver transplant.

5. 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:

Subjects must not:

1. Be receiving a living donor liver transplant.

2. Be receiving a donor liver with a cold ischemia time less than 5 hours or greater than 12 hours.

3. 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).

4. Be receiving any prostanoid to treat portopulmonary hypertension.

5. Have had a failed liver transplant within the previous 180 days.

6. Be undergoing multi-organ transplantation (transplantation of organs other than liver at the same time as the liver transplantation procedure).

7. Have fulminant hepatic failure

8. Model for end stage liver diseases (MELD) score of > 40

9. Hepatitis C positive donor liver

10. On renal replacement therapy at the time of study

11. Be receiving any non-standard immunosuppression protocol or other non-standard treatment that could affect interpretation of the study results.

12. Those currently receiving treatment for portopulmonary hypertension.

13. Those with significant cardiovascular disease including treatment with inotropes.

14. Have any known hypersensitivity to prostaglandins, prostacyclin or treprostinil.

15. If female, be pregnant or nursing (as confirmed by urine pregnancy test at Baseline).

16. HIV positive

17. Individuals who are allergic to iodine

18. Individuals who are receiving methylene blue

19. A donor liver with macrosteatosis greater than 40% if biopsy results are available