Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-OLE)

Overview

About this study

The purpose of this study is to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with fibrotic interstitial lung disease

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Subject gives voluntary informed consent to participate in the study.
2. The subject participated in Study RIN-PF-301 or Study RIN-PF-303 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301 or Study 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 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 5/30/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Teng Moua, M.D.

Open for enrollment

Contact information:

Shannon Daley C.C.R.C., CCRP

(507) 293-0637

Daley.Shannon@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Augustine Lee, M.D.

Open for enrollment

Contact information:

Inna Dawson CCRP

Abrea.Inna@mayo.edu

More information

Publications

Publications are currently not available