Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Withdrawn before enrolling · Phase 2
Conditions studied: Pulmonary Hypertension, Pulmonary Fibrosis
In brief
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.
Key facts
- Study ID
- NCT02603068
- Run by
- United Therapeutics
- People needed
- 0
- Starts
- 2016-02-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2016-02-09
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Banner University Medical Center Phoenix Advanced Lung Disease — Phoenix, Arizona, United States
- University of California, Los Angeles - Pulmonary Division — Los Angeles, California, United States
- University of California - Davis Medical Group — Sacramento, California, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Johns Hopkins University — Baltiomore, Maryland, United States
- Oregon Health and Science University — Portland, Oregon, United States
- CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.