Status:
ENROLLING_BY_INVITATION
Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
Lead Sponsor:
United Therapeutics
Conditions:
Idiopathic Pulmonary Fibrosis
Interstitial Lung Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.
Detailed Description
Study RIN-PF-302 is a Phase 3, multicenter, open-label extension (OLE) study for eligible subjects who completed Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 to evaluate the long-term safet...
Eligibility Criteria
Inclusion
- Subject gives voluntary informed consent to participate in the study.
- The subject participated in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.
- Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
- Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
- In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
Exclusion
- Subject is pregnant or lactating.
- In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
- Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement). Subjects participating in non-interventional, observational, or registry studies are eligible.
Key Trial Info
Start Date :
September 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
1850 Patients enrolled
Trial Details
Trial ID
NCT04905693
Start Date
September 6 2022
End Date
June 1 2026
Last Update
December 22 2025
Active Locations (190)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Clinical Trials Center of Middle Tennessee
Franklin, Arizona, United States, 37067
3
Banner University Medical Center-Phoenix
Phoenix, Arizona, United States, 85006
4
St. Joseph's Hospital and Medical Center - Norton Thoracic Institute
Phoenix, Arizona, United States, 85013