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

Completed

Conditions studied: Portopulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT01028651

Run by

United Therapeutics

People needed

13

Starts

2011-01-01

Expected to finish

2013-04-01

Last updated by the study team

2017-02-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must:
• Had portal hypertension.
• Be otherwise suitable candidates for OLT.
• Had severe pulmonary arterial hypertension (PAH) defined as a resting mean pulmonary arterial pressure (mPAP) >35 mmHg and pulmonary vascular resistance (PVR) ≥3 Wood Units (WU) by right heart catheterization (RHC) performed as part of standard of care evaluation within 90 days of enrollment.
• Treprostinil therapy must be recommended by the treating physician per standard of care.
• Be NYHA Functional Class II, III, or IV.
• Had pulmonary capillary wedge (PCW) pressure ≤18 mmHg and transpulmonary gradient (TPG) ≥15 mmHg.

You may not qualify if…

• Patients must not:
• Had received any any investigational therapy as part of a clinical trial for any indication within 30 days prior to enrollment.
• Had a change in dose of treatment for PAH (bosentan [Tracleer], ambrisentan [Letairis], tadalafil [Adcirca], or sildenafil [Revatio]), within 30 days prior to enrollment. That is, subjects may have been treated with any of these agents provided the dose was stable for at least 30 days prior to enrollment.
• Had renal failure requiring hemodialysis.

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States
• Emory Univeristy — Atlanta, Georgia, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• University of Texas, Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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