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

NCT01884038 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-12-19

No results posted yet for this study

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.

Conditions

  • Liver Transplant

Interventions

DRUG

treprostinil sodium

A single dose strength of treprostinil sodium (1.0 mg/mL) and matching placebo will be provided in 20-mL multi-dose vials. The study drug will be started after induction of anesthesia and increased incrementally to a target dose of 10 ng/kg/min during surgery and 48 hours post-operative

DRUG

Placebo

Sponsors & Collaborators

  • University of Pittsburgh Medical Center

    collaborator OTHER

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Amadeo Marcos, MD · University of Pittsburgh Medical Center

  • Raman Venkataramanan, Ph.D, F.C.P. · University of Pittsburgh Medcial Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01884038 on ClinicalTrials.gov