Overview

Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

Status:
Not yet recruiting
Trial end date:
2026-05-01
Target enrollment:
0
Participant gender:
All
Summary
Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with fibrotic lung disease.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
United Therapeutics
Treatments:
Treprostinil
Criteria
Inclusion Criteria:

1. Subject gives voluntary informed consent to participate in the study.

2. The subject participated in Study RIN-PF-301 and remained on study drug and completed
all scheduled study visits or was enrolled in Study RIN-PF-301 at the time that the
study or study subject was discontinued by the Sponsor.

3. Women of childbearing potential must be non-pregnant (as confirmed by a urine
pregnancy test at Screening and Baseline) and non-lactating, and will 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.

4. Males with a partner of childbearing potential must 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.

Exclusion Criteria:

1. Subject is pregnant or lactating.

2. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a
risk to the subject's overall health.