An Open-label Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease

The purpose of this study is to investigate long-term treatment with a drug called inhaled treprostinil (brand name Tyvaso®) in people with Idiopathic Pulmonary Fibrosis (IPF). 

For more information, visit: https://clinicaltrials.gov/study/NCT04905693

Inova Fairfax Medical Center
3300 Gallows Rd
Falls Church, VA, 22042
 

A subject is eligible for inclusion in this study if all the following criteria apply:
1. Subject gives voluntary informed consent to participate in the study.
2. The subject participated in RIN-PF-301, RIN-PF-303, or RIN-PF-305 and had 1 of the 
following applied:
a. Remained on study drug and completed all scheduled study visits
b. Was enrolled in RIN-PF-301, RIN-PF-303, or RIN-PF-305 at the time that the study 
or study subject was discontinued by the Sponsor for reasons other than safety.
3. 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 do 1 of the 
following:
a. Abstain from intercourse (when it is in line with their preferred and usual lifestyle)
b. Use 2 medically acceptable, highly effective forms of contraception for the duration 
of the study, and at least 30 days after discontinuing study drug. Medically
acceptable, highly effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable) and barrier methods (such as a 
condom or diaphragm) when used with a spermicide.
Women who are successfully sterilized or postmenopausal are not considered to be of 
reproductive potential.
4. 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.
5. 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

A subject is not eligible for inclusion in this study if any of the following criteria apply:
1. Subject is pregnant or lactating.
2. In the opinion of the Investigator, enrollment in RIN-PF-302 would represent a risk to the 
subject's overall health. 
3. 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