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Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age

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

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Site details revised at 38 of 38 sitesv33 Show 1 more changeShow less
    • Site details revised at 38 of 38 sites
  2. Study sites revised (38)v32 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv31
  4. Study sites: 37 to 38v30
  5. Site details revised at 2 of 37 sitesv29
Show 27 earlier versionsHide 27 earlier versions
  1. Site details revised at 2 of 37 sitesv28
  2. Study sites: 35 to 37v27
  3. Study sites: 34 to 35v26
  4. Site details revised at 2 of 34 sitesv25
  5. Re-verified, no change to tracked fieldsv24
  6. Site details revised at 5 of 34 sitesv23
  7. Site details revised at 1 of 34 sitesv22
  8. Site details revised at 2 of 34 sitesv21
  9. Primary and study completion dates: Jun 2030 to Jun 30, 2030 Study sites revised (34)v20 Show 1 more changeShow less
    • Study sites revised (34)

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv19
  11. Trial status: Active, Not Recruiting to Recruiting Study sites revised (34)v18 Show 1 more changeShow less
    • Study sites revised (34)

    See this version in full on ClinicalTrials.gov ↗

  12. Re-verified, no change to tracked fieldsv17
  13. Trial status: Recruiting to Active, Not Recruiting Site details revised at 34 of 34 sitesv16 Show 1 more changeShow less
    • Site details revised at 34 of 34 sites
  14. Site details revised at 1 of 34 sitesv15
  15. Study sites: 33 to 34v14
  16. Site details revised at 1 of 33 sitesv13
  17. Study sites: 32 to 33v12
  18. Study sites: 29 to 32v11
  19. Study sites: 27 to 29v10
  20. Study sites: 22 to 27v9
  21. Study sites: 12 to 22v8
  22. Study sites: 10 to 12v7
  23. Study sites: 8 to 10v6
  24. Site details revised at 2 of 8 sitesv5
  25. Study sites: 7 to 8v4
  26. Study sites: 4 to 7v3
  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Start date changed from estimate of Jun 2022 to Jun 21, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 4
    • Start date changed from estimate of Jun 2022 to Jun 21, 2022
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Trial Details
NCT Number NCT05422222
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Cystic Fibrosis
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov