An Open-label Extension Study of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis

Phase 3

• Conditions: Interstitial Lung Disease (ILD); Lungfibrosis; 10024967

• Registration Number: NL-OMON56110
• Lead Sponsor: nited Therapeutics Corp.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

1. Subject gives voluntary informed consent to participate in the study.
2. The subject participated in RIN-PF-301 or RIN-PF-303 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 or RIN-PF-303 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 OLE Entry Visit and Baseline) and non-lactating, and will 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 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 RIN-PF-302 would represent
a risk to the
subject*s overall health.

Study & Design

• Study Type: Interventional
• Study Design: Not specified