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Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions: ELX/TEZ/IVA (Drug), IVA (Drug) to ELX/TEZ/IVA (Drug), IVA (Drug) Site details revised at 7 of 81 sites Show 1 more changeShow less
    • Site details revised at 7 of 81 sites
  2. 6 versions Re-verified since Jan 20, 2026, no change to tracked fieldsv24-v29
  3. Study sites revised (81)v23 See this version in full on ClinicalTrials.gov ↗
  4. Primary and study completion dates: Apr 2027 to Apr 6, 2027v22
  5. Primary and study completion dates: Apr 2025 to Apr 2027 Primary endpoint revised · Eligibility criteria expanded, about 36 words · Secondary endpoints revised (6)v21 Show 3 more changesShow less
    • Primary endpoint revised
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints revised (6)

    See this version in full on ClinicalTrials.gov ↗

Show 19 earlier versionsHide 19 earlier versions
  1. Trial status: Enrolling by Invitation to Active, Not Recruiting Enrollment target: estimated 270 to confirmed 297v20 Show 1 more changeShow less
    • Enrollment target: estimated 270 to confirmed 297
  2. Study sites: 77 to 81v19
  3. Study sites: 74 to 77v18
  4. Study sites: 70 to 74v17
  5. Study sites: 66 to 70v16
  6. Study sites: 58 to 66v15
  7. Study sites: 54 to 58v14
  8. Study sites: 52 to 54v13
  9. Study sites: 43 to 52v12
  10. Study sites: 40 to 43v11
  11. Study sites: 32 to 40v10
  12. Trial status: Recruiting to Enrolling by Invitation Study sites: 19 to 32v9 Show 1 more changeShow less
    • Study sites: 19 to 32
  13. Study sites: 13 to 19v8
  14. Study sites: 11 to 13v7
  15. Study sites: 8 to 11v6
  16. Study sites: 5 to 8v5
  17. Study sites: 1 to 5v4
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 2022 to Nov 23, 2022v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2022 to Nov 23, 2022
  19. Start date: Sep 2022 to Nov 2022 Primary and study completion dates: Mar 2025 to Apr 2025v2 Show 1 more changeShow less
    • Primary and study completion dates: Mar 2025 to Apr 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study will evaluate the long-term safety, efficacy and pharmacodynamics of ELX/TEZ/IVA in participants with cystic fibrosis (CF) with at least 1 non-F508del ELX/TEZ/IVA-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Trial Details
NCT Number NCT05331183
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Cystic Fibrosis
Enrollment 297 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov