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.
This study will evaluate how oral treprostinil can affect pulmonary vascular resistance, as assessed by right heart catheterization, and exercise capacity, as assessed by the Six-Minute Walk Test. This is a 16-week study that will involve at least 10 clinical trial centers. The expected enrollment period is around 24 months and 52 subjects will be entered into the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Oral treprostinil will be administered as TID dosing for up to 16 Weeks.
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
Change in pulmonary vascular resistance (PVR)
Change in PVR between iMTD and fixed dose groups
Time frame: Baseline to Week 16
Change in Six-minute walk distance (6MWD)
Change in 6MWD between iMTD and fixed dose groups
Time frame: Baseline to Week 16
Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)
Change in NT-ProBNP between iMTD and fixed dose groups
Time frame: Baseline to Week 16
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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