Clinical trial NCT02603068: Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Official title: Multicenter, Randomized, Open Label Trial to Evaluate the Safety and Efficacy of Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Pulmonary Hypertension
Pulmonary Fibrosis
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in pulmonary vascular resistance (PVR)
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change in Six-minute walk distance (6MWD)
timeFrame: Baseline to Week 16
measure: Change in N-terminal pro-brain natriuretic peptide (NT-ProBNP)
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenix Advanced Lung Disease
state: Arizona
city: Los Angeles
country: United States
facility: University of California, Los Angeles - Pulmonary Division
state: California
city: Sacramento
country: United States
facility: University of California - Davis Medical Group
state: California
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Baltiomore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: CLC Pulmonary Hypertension Clinic Division of Pulmonary, Allergy and Critical Care Medicine UPMC
state: Pennsylvania
Study officials:
affiliation: University of California, Los Angeles - Pulmonary Division
name: Rajan Saggar, MD
role: PRINCIPAL_INVESTIGATOR
References: