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Status: Withdrawn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 transplantationArea 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
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