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Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

Study acronym: TETON-OLE
StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 5 months later Jun 2026 → Dec 2029
See other at-risk trials from United Therapeutics

Record History

The 50 most recent of 89 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial sites reduced: 193 → 190 locations
  2. Eligibility criteria expanded, about 8 words Study description revised · Site details revised at 12 of 193 sites Show 2 more changesShow less
    • Study description revised
    • Site details revised at 12 of 193 sites
  3. Study sites: 192 to 193v87
  4. Primary and study completion pushed from Jun 2026 to Dec 2029 Study sites: 194 to 192v86 Show 1 more changeShow less
    • Study sites: 194 to 192
  5. 2 versions Re-verified since May 13, 2026, no change to tracked fieldsv84-v85
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites: 193 to 194v83
  2. 5 versions Re-verified since Feb 5, 2026, no change to tracked fieldsv78-v82
  3. Study sites: 192 to 193v77
  4. Study sites: 191 to 192v76
  5. Study sites: 190 to 191v75
  6. Study sites: 189 to 190v74
  7. Study sites: 188 to 189v73
  8. Study sites: 187 to 188v72
  9. Study sites: 186 to 187v71
  10. Study sites: 185 to 186v70
  11. Enrollment target: 792 to 1850 Site details revised at 19 of 185 sitesv69 Show 1 more changeShow less
    • Site details revised at 19 of 185 sites
  12. Study sites revised (185)v68 See this version in full on ClinicalTrials.gov ↗
  13. Study sites: 183 to 185v67
  14. Study sites revised (183)v66 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 169 to 183v65
  16. Study sites: 167 to 169v64
  17. Study sites: 164 to 167v63
  18. Study sites: 159 to 164v62
  19. Study sites: 151 to 159v61
  20. Study sites: 149 to 151v60
  21. Study sites: 147 to 149v59
  22. Study sites: 144 to 147v58
  23. Study sites revised (144)v57 See this version in full on ClinicalTrials.gov ↗
  24. Study sites: 140 to 144v56
  25. Study sites: 139 to 140v55
  26. Primary completion date: Jun 2024 to Jun 2026 Study sites: 125 to 139v54 Show 1 more changeShow less
    • Study sites: 125 to 139
  27. Study sites: 123 to 125v53
  28. Study sites: 122 to 123v52
  29. Study sites: 117 to 122v51
  30. Study sites: 116 to 117v50
  31. Re-verified, no change to tracked fieldsv49
  32. Study sites: 115 to 116v48
  33. Study sites: 113 to 115v47
  34. Study sites: 103 to 113v46
  35. Study sites: 101 to 103v45
  36. Study sites: 86 to 101v44
  37. Study sites: 85 to 86v43
  38. Study sites: 84 to 85v42
  39. Study sites: 83 to 84v41
  40. Study sites: 78 to 83v40
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04905693
Lead Sponsor United Therapeutics
Conditions Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Progressive Pulmonary Fibrosis
Enrollment 1,850 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov