Oral Treprostinil in Subjects With Pulmonary Hypertension Associated With Pulmonary Fibrosis

United Therapeutics

Status and phase

Withdrawn

Phase 2

Conditions

Pulmonary Fibrosis

Pulmonary Hypertension

Treatments

Drug: Oral treprostinil

Study type

Interventional

Funder types

Industry

Identifiers

NCT02603068

TDE-PH-204

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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