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NCT05571059

Oral Ifetroban in Patients With Idiopathic Pulmonary Fibrosis (IPF)

StatusRecruiting
PhasePhase 2
Primary completion (estimated)

At risk: Primary completion moved at least 11 months later.

See at-risk trials from Cumberland Pharmaceuticals

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Record History

All 25 versions: 24 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jan 2027 to Jan 2028
    • Eligibility criteria expanded, about 22 words
    • Study sites: 19 to 20
    v25
  2. Study sites: 18 to 19v24
  3. Primary and study completion dates: Jan 2026 to Jan 2027
    • Study sites: 17 to 18
    v23
  4. Study sites: 16 to 17v22
  5. Site contacts updated at 3 of 16 sitesv21
Show 18 earlier versionsHide 18 earlier versions
  1. Site contacts updated at 16 of 16 sitesv20
  2. Study sites: 14 to 16v19
  3. Study sites: 13 to 14v18
  4. Study sites: 12 to 13v17
  5. Study sites: 11 to 12v16
  6. Study sites: 8 to 11v15
  7. Study sites: 7 to 8v14
  8. Eligibility criteria shortened, about 6 words
    • Study sites: 6 to 7
    v13
  9. Study sites: 5 to 6v11
  10. Study sites: 2 to 5v10
  11. Study sites: 1 to 2v9
  12. Trial status: Not Yet Recruiting to Recruitingv8 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Dec 2025 to Jan 2026
    • Study completion date: Dec 2026 to Jan 2026
    • Start date changed from estimate of Dec 2023 to Jan 31, 2024
  13. Start date: Sep 2023 to Dec 2023
    • Primary completion date: Sep 2025 to Dec 2025
    • Study completion date: Sep 2026 to Dec 2026
    v7
  14. Primary completion date: May 2025 to Sep 2025
    • Study completion date: Apr 2027 to Sep 2026
    • Start date: Aug 2023 to Sep 2023
    v6
  15. Start date: Jun 2023 to Aug 2023v5
  16. Eligibility criteria expanded, about 7 words
    • Study description shortened, about 4 words
    v4
  17. Eligibility criteria expanded, about 5 wordsv3
  18. Enrollment target: 200 to 128v2 Show 7 more changesShow less
    • Start date: Mar 2023 to Jun 2023
    • Eligibility criteria shortened, about 210 words
    • Primary endpoint revised
    • Primary completion date: Apr 2025 to May 2025
    • Secondary endpoints: 6 to 10
    • Study description shortened, about 9 words
    • Study title shortened, about 5 words
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change from baseline in Forced Vital Capacity (FVC) in mL
Timeframe: Baseline through 12 months

Secondary (10)

Time to the first occurrence of any of the components of the composite endpoint: time to first acute IPF exacerbation, first hospitalization for respiratory cause, or death
Time to first acute IPF exacerbation or death
Proportion of patients with acute exacerbations of lung fibrosis
Time to hospitalization for respiratory cause or death
Change from baseline in quality of life (SOBQ)
Show 5 moreShow less
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Cough domain score
Change from baseline in Living with Pulmonary Fibrosis (L-PF) Symptoms Fatigue domain score
Time to death
Incidence of Treatment Emergent Adverse Events (safety & tolerability)

Arms and interventions

Ifetroban SodiumExperimental

Drug: Ifetroban Oral capsule, 250 mg, once daily for 12 months

PlaceboPlacebo comparator

Drug: Placebo Matching placebo, oral capsule, once daily for 12 months

Drugs: Ifetroban Sodium, Placebo

Sites

20 sites in 1 country