Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05444257 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy

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

Record History

  1. Interventions: VX-121/TEZ/D-IVA (Drug) to VX-121/TEZ/D-IVA (Drug) Site details revised at 47 of 195 sites · Eligibility criteria expanded, about 4 words Show 2 more changesShow less
    • Site details revised at 47 of 195 sites
    • Eligibility criteria expanded, about 4 words
  2. Study sites revised (195)v41 See this version in full on ClinicalTrials.gov ↗
  3. 2 versions Re-verified since Apr 28, 2026, no change to tracked fieldsv39-v40
  4. Primary and study completion dates: Oct 2026 to Oct 30, 2026 Site details revised at 3 of 195 sitesv38 Show 1 more changeShow less
    • Site details revised at 3 of 195 sites
  5. Primary and study completion dates: Oct 2025 to Oct 2026 Eligibility criteria expanded, about 51 words · Secondary endpoints: details revised at 3 of 3 entriesv37 Show 2 more changesShow less
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints: details revised at 3 of 3 entries

    See this version in full on ClinicalTrials.gov ↗

Show 35 earlier versionsHide 35 earlier versions
  1. Trial status: Enrolling by Invitation to Active, Not Recruiting Enrollment target: estimated 850 to confirmed 822v36 Show 1 more changeShow less
    • Enrollment target: estimated 850 to confirmed 822
  2. Study sites: 192 to 195v35
  3. Study sites: 190 to 192v34
  4. Study sites: 184 to 190v33
  5. Study sites: 180 to 184v32
  6. Study sites: 176 to 180v31
  7. Study sites: 169 to 176v30
  8. Study sites: 164 to 169v29
  9. Study sites: 159 to 164v28
  10. Study sites: 154 to 159v27
  11. Study sites: 151 to 154v26
  12. Study sites: 148 to 151v25
  13. Study sites: 144 to 148v24
  14. Study sites: 133 to 144v23
  15. Study sites: 125 to 133v22
  16. Study sites: 114 to 125v21
  17. Study sites: 104 to 114v20
  18. Study sites: 100 to 104v19
  19. Study sites: 93 to 100v18
  20. Study sites: 88 to 93v17
  21. Study sites: 72 to 88v16
  22. Study sites: 63 to 72v15
  23. Study sites: 56 to 63v14
  24. Study sites: 55 to 56v13
  25. Study sites: 48 to 55v12
  26. Study sites: 45 to 48v11
  27. Study sites: 33 to 45v10
  28. Study sites: 28 to 33v9
  29. Trial status: Recruiting to Enrolling by Invitation Study sites: 17 to 28v8 Show 1 more changeShow less
    • Study sites: 17 to 28
  30. Study sites: 12 to 17v7
  31. Study sites: 9 to 12v6
  32. Study sites: 6 to 9v5
  33. Study sites: 3 to 6v4
  34. Study sites: 1 to 3v3
  35. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Nov 2022 to Nov 8, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Nov 2022 to Nov 8, 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 long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Trial Details
NCT Number NCT05444257
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Cystic Fibrosis
Enrollment 822 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov