This study is accepting new patients by invitation only

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

a study on High Blood Pressure Interstitial Lung Disease Fibrosis

Summary

for people ages 18 years and up (full criteria)
at UC Davis UCSD UCSF
study started
estimated completion

Description

Summary

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).

Official Title

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

Keywords

Pulmonary Hypertension Interstitial Lung Disease Combined Pulmonary Fibrosis and Emphysema Treprostinil PH ILD CPFE 6 Minute Walk Test Lung Diseases Hypertension, Pulmonary Pulmonary Fibrosis Lung Diseases, Interstitial Hypertension Emphysema Inhaled Treprostinil

Eligibility

You can join if…

Open to people ages 18 years and up

  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:
  4. Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or
  5. Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug.
  6. Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

You CAN'T join if...

  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.

Locations

  • University of California, San Francisco-Fresno
    Fresno California 93701 United States
  • University of California San Diego
    La Jolla California 92093 United States
  • University of California Davis Medical Center
    Sacramento California 95817 United States
  • Kaiser Permanente
    San Francisco California 94115 United States
  • Cedars-Sinai Medical Center
    Beverly Hills California 90211 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
United Therapeutics
ID
NCT02633293
Phase
Phase 2/3
Study Type
Interventional
Last Updated