Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

Phase 2

Withdrawn

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Individual Maximum Tolerated Dose (iMTD)	Oral treprostinil	Subjects are allowed to titrate oral treprostinil up to a maximum dose of 12 mg TID.
Fixed Dose (FD)	Oral treprostinil	Subjects are allowed to titrate oral treprostinil up to a maximum dose of 1 mg TID.

Primary Outcome Measures

Name	Time	Method
Change in pulmonary vascular resistance (PVR)	Baseline to Week 16	Change in PVR between iMTD and fixed dose groups

Secondary Outcome Measures

Name	Time	Method
Change in Six-minute walk distance (6MWD)	Baseline to Week 16	Change in 6MWD between iMTD and fixed dose groups
Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)	Baseline to Week 16	Change in NT-ProBNP between iMTD and fixed dose groups

Locations (7): Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC
🇺🇸
Pittsburgh, Pennsylvania, United States
Banner University Medical Center Phoenix Advanced Lung Disease
🇺🇸
Phoenix, Arizona, United States
University of California - Davis Medical Group
🇺🇸
Sacramento, California, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
University of California, Los Angeles - Pulmonary Division
🇺🇸
Los Angeles, California, United States
Johns Hopkins University
🇺🇸
Baltiomore, Maryland, United States

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