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

Information source: United Therapeutics
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Transplant

Intervention: treprostinil sodium (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Withdrawn

Sponsored by: United Therapeutics

Official(s) and/or principal investigator(s):
Amadeo Marcos, MD, Principal Investigator, Affiliation: University of Pittsburgh
Raman Venkataramanan, Ph.D, F.C.P., Principal Investigator, Affiliation: University of Pittsburgh Medcial Center

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.

Clinical Details

Official title: A Single Center, Randomized, Double-Blind, Parallel Placebo-Controlled Study of the Safety and Efficacy of Perioperative Remodulin in Orthotopic Liver Transplant Recipients

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome:

Duration of the initial hospitalization (days) following transplantation

Area under the curve (AUC) of serum aspartate transaminase (AST) levels.

Secondary outcome:

Serum AST and alanine transaminase (ALT ) levels after transplant (Peak and Area Under the Curve [AUC])

Primary allograft nonfunction defined as patient death or retransplant within 30 days due to liver failure

Graft survival

Subject survival at

Post-transplant renal function

Duration of time spent in the intensive care unit (ICU; days) during the initial hospitalization.

Intra-operative blood product usage

Death from any cause

Total costs for initial transplant hospitalization

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) Recent reviews summarize the pharmacologic rationale and nonclinical and clinical experience supporting for the use of prostanoids, including prostacyclin and its analogs, in reducing early morbidity and mortality associated with liver transplantation. 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. Additionally, the reduction in serum creatinine and reduced need for post-operative dialysis observed in some studies has implications in protecting the kidneys from the nephrotoxic affects of the immunosuppressant agents, especially during the early post-operative period. As a chemically stable analog of prostacyclin (PGI2), peri-operative intravenous administration of Remodulin is hypothesized to ameliorate or prevent reperfusion damage and thereby decrease hospitalization time and improve the clinical outcome of liver transplantation, compared to placebo control. Remodulin, as a prostanoid, is expected to facilitate restoration of the blood supply to the revascularized graft, and to provide the well-characterized protective effects of this class of compounds in liver transplant patients.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

University of Pittsburgh Medical Center, Starzl Transplantation Institute, Pittsburgh, Pennsylvania 15213, United States
Additional Information

Starting date: June 2008
Last updated: June 20, 2013

Page last updated: August 23, 2015

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