An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE



Status:Enrolling by invitation
Conditions:Lung Cancer, Chronic Obstructive Pulmonary Disease, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension), Pulmonary, Pulmonary, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:September 2016
End Date:November 2022

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An Open-Label Extension Study of Inhaled Treprostinil in Subjects With Pulmonary Hypertension Due to Parenchymal Lung Disease

This is a multicenter, open-label trial to evaluate the safety and efficacy of inhaled
treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with
interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE).
The study will include about 266 patients who completed all required assessments in the
RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your
participation in this study is voluntary and will last until you discontinue from the study
or the study ends. The study will continue until each subject reaches the Week 108 visit or
until inhaled treprostinil become commercially available for patients with PH associated with
ILD including CPFE (whichever is sooner).


Inclusion Criteria:

1. Subject voluntarily gives informed consent to participate in the study.

2. The subject participated in study RIN-PH-201, remained on study drug, was compliant
with RIN-PH-201 study procedures or was enrolled in study RIN-PH-201 at the time that
the study was discontinued by the sponsor.

3. Females of reproductive potential must be non-pregnant (as confirmed by a urine
pregnancy test at Baseline) and non-lactating, and will:

- Either abstain from intercourse (when it is in line with their preferred and
usual lifestyle), or

- Use two medically acceptable, highly-effective forms of contraception for the
duration of study, and at least 30 days after discontinuing study drug.

4. Males must use a condom for the duration of treatment and for at least 48 hours after
discontinuing study drug.

Exclusion Criteria:

1. The subject is pregnant or lactating.

2. The subject was prematurely discontinued from study RIN-PH-201.

3. The subject developed a concurrent illness or condition during the conduct of
RIN-PH-201 which, in the opinion of the Investigator, would represent a risk to
overall health if they enrolled in this study.
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