drugset / Trial / NCT02633293

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

NCT02633293

Phase 2/3 Terminated 243 enrolled United Therapeutics
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2016-09-15
Primary completion
2021-08-01
Completion
2021-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Treprostinil Other / unclassified 90 ug Inhaled