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A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension

NCT01028651 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2017-02-24

Study results available
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Summary

This was a multicenter, prospective, observational, open-label study. Patients meeting inclusion/exclusion criteria received treatment with treprostinil as recommended by their treating physicians and were followed according to standard of care. This observational study collected clinical data and biologic specimens from patients who were treated for portopulmonary hypertension (PoPH), with a goal of achieving hemodynamic parameters appropriate for orthotopic liver transplantation candidacy, including mean pulmonary arterial pressure (mPAP) less than 35 mmHg and pulmonary vascular resistance (PVR) less than 3 Wood-units (WU) at Week 24 in patients with severe PoPH.

Conditions

Interventions

DRUG

Treprostinil

Remodulin is supplied in concentrations of 1, 2.5 , 5, and 10 mg/mL and can be administered as supplied or diluted for intravenous (IV) infusion prior to administration. Remodulin is indicated for subcutaneous (SC) or IV use only as a continuous infusion. Remodulin is preferably infused subcutaneously, but can be administered by a central IV line if the SC route is not tolerated. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated because of systemic effects, the infusion rate should be reduced to 0.625 ng/kg/min.

Sponsors & Collaborators

  • University of California, Los Angeles

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • University of Texas

    collaborator OTHER

  • Emory University

    collaborator OTHER

  • United Therapeutics

    lead INDUSTRY

Principal Investigators

  • Rajan Saggar, MD · University of California, Los Angeles

  • Micah Fisher, MD · Emory University

  • Aaron Waxman, MD, PhD · Brigham and Women's Hospital

  • Sonja Bartolome, MD · UT Southwestern Medical Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01028651 on ClinicalTrials.gov