Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

• Status: Withdrawn
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This multicenter, randomized, open-label study will assess the safety and efficacy of oral treprostinil in subjects diagnosed with pulmonary hypertension associated with pulmonary fibrosis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: United Therapeutics
• Treatments: Treprostinil

Criteria

Inclusion Criteria:

• Voluntarily gives informed consent

• Must meet criteria for lung transplant referral but is not required to be on an active lung transplant list

• Stable and significant diffuse parenchymal lung disease with a diagnosis of interstitial lung disease

• 6MWD greater than or equal to 75 meters

• Right heart catheterization with a mean pulmonary arterial pressure >= 30 mgHg, pulmonary capillary wedge pressure <= 15 mmHg and pulmonary vascular resistance > 240 dynes

• Echo-Doppler examination showing evidence of right ventricular dysfunction and normal left diastolic ventricular function

• Either not receiving any PAH-approved oral therapy, or is receiving monotherapy (ERA, PDE-5I, or riociguat) for > 60 days and receiving a stable dose for > 30 days prior to enrollment

• Able to communicate effectively with study personnel and will to be cooperative with protocol requirements

Exclusion Criteria:

• History of repaired or unrepaired congenital heart disease

• Received prostanoid therapy in the past 30 days, or has shown an intolerance or lack of efficacy to prostanoid therapy resulting in discontinuation or inability to titrate prostacyclins

• Diagnosis of sarcoidosis

• History of thromboembolic disease

• Chronic renal insufficiency

• Pregnancy or lactating

• Currently receiving an investigational drug, has an investigational device in place, or has participated in an investigational drug or device study within 30 days prior to Screening