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

Stopped early · Phase 2/Phase 3

Conditions studied: Pulmonary Hypertension, Interstitial Lung Disease, Combined Pulmonary Fibrosis and Emphysema

In brief

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).

Key facts

Study ID

NCT02633293

Run by

United Therapeutics

People needed

243

Starts

2016-09-15

Expected to finish

2021-08-01

Last updated by the study team

2022-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject voluntarily gives informed consent to participate in the study.
• 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.
• 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.
• Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

You may not qualify if…

• The subject is pregnant or lactating.
• The subject was prematurely discontinued from study RIN-PH-201.
• 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.

Where it is running

• IMC-Diagnostic & Medical Clinic — Mobile, Alabama, United States
• Arizona Pulmonary Specialists, Ltd. — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Cedars-Sinai Medical Center — Beverly Hills, California, United States
• University of California, San Francisco-Fresno — Fresno, California, United States
• University of California San Diego — La Jolla, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• University of Southern California — Los Angeles, California, United States
• Department of Veterans Affairs Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Pacific Pulmonary Medical Group — Riverside, California, United States
• University of California Davis Medical Center — Sacramento, California, United States
• Kaiser Permanente — San Francisco, California, United States
• University of Colorado Hospital - Cardiac and Vascular Center — Aurora, Colorado, United States
• National Jewish Health — Denver, Colorado, United States
• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• MedStar Heart & Vascular Institute — Washington D.C., District of Columbia, United States
• Florida Lung, Asthma & Sleep Specialists, P.A. — Celebration, Florida, United States
• St. Francis Sleep, Allergy and Lung Institute — Clearwater, Florida, United States
• University of Florida Clinical Research Center — Gainesville, Florida, United States
• University of Florida College of Medicine, Jacksonville — Jacksonville, Florida, United States
• Mayo Clinic Jacksonville — Jacksonville, Florida, United States
• St. Vincent's Lung, Sleep, and Critical Care Specialists — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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