Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

NCT04905693
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Enrolling by invitation
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Participants
1,850
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Lead sponsor
United Therapeutics
clinicaltrials.gov
Start date
2022-09-06
clinicaltrials.gov
Number of sites
192
clinicaltrials.gov

Summary
Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.
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Acronym
TETON-OLE
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Short title
Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
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Official title
An Open-label Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (TETON-OLE)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Enrolling by invitation
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-12-01
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First posted
2021-05-28
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Registry last updated
2026-07-28
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Primary completion date
2029-12-01
clinicaltrials.gov
Start date
2022-09-06
clinicaltrials.gov

Participants
1,850
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Participant count basis
Estimated
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Planned participants
1,850
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Protocol amendments
3
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Number of sites
192
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
United Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT04905693
clinicaltrials.gov
ClinicalTrials.gov ID
NCT04905693
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF

    Timeframe: Baseline to 6 years

    Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Healthy volunteers
No

  1. Subject gives voluntary informed consent to participate in the study.
  2. The subject participated in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301, Study RIN-PF-303, or Study 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 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 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.

  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.
  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.
Sources for eligibility
clinicaltrials.gov

  • The University of Alabama at BirminghamBirmingham, United States
  • Clinical Trials Center of Middle TennesseeFranklin, United States
  • Banner University Medical Center-PhoenixPhoenix, United States
  • St. Joseph's Hospital and Medical Center - Norton Thoracic InstitutePhoenix, United States
  • University of ArizonaTucson, United States
  • UC San Diego HealthLa Jolla, United States
  • David Geffen School of Medicine at UCLALos Angeles, United States
  • NewportNativeMD, IncNewport Beach, United States
  • Palmtree Clinical Research, Inc.Palm Springs, United States
  • UC Davis Health Medical CenterSacramento, United States
  • University of California San FranciscoSan Francisco, United States
  • Stanford University School of MedicineStanford, United States
  • National Jewish HealthDenver, United States
  • University of Florida Health at ShandsGainesville, United States
  • Ascension St. Vincent'sJacksonville, United States
  • Mayo Clinic FloridaJacksonville, United States
  • Pulmonary Disease Specialists, PA d/b/a PDS ResearchKissimmee, United States
  • Central Florida Pulmonary Group, PAOrlando, United States
  • Coastal Pulmonary & Critical Care PLCSt. Petersburg, United States
  • University of South Florida HealthTampa, United States
  • Cleveland Clinic FloridaWeston, United States
  • Piedmont Healthcare AtlantaAtlanta, United States
  • Emory UniversityAtlanta, United States
  • Northwestern Memorial HospitalChicago, United States
  • Loyola University Medical CenterMaywood, United States

And 167 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (3)

Targets (2)