Extension Study of Inhaled Treprostinil in Subjects with Fibrotic Lung Disease
- Conditions
- Fibrotic Lung DiseaseMedDRA version: 20.0Level: LLTClassification code: 10025089Term: Lung fibrosis interstitial Class: 10038738Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-504471-25-00
- Lead Sponsor
- nited Therapeutics Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1850
Subject gives voluntary informed consent to participate in the study., 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., 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., 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.
Subject is pregnant or lactating., In the opinion of the Investigator, enrollment in 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method