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Evaluation of Long-Term Safety and Efficacy of Vanzacaftor/Tezacaftor/Deutivacaftor in Cystic Fibrosis Participants 1 Year of Age and Older

StatusEnrolling by Invitation
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv20
  2. Study sites: 36 to 37v19
  3. Study sites: 35 to 36v18
  4. Study sites: 32 to 35v17
  5. Study sites revised (32)v16 See this version in full on ClinicalTrials.gov ↗
Show 14 earlier versionsHide 14 earlier versions
  1. Primary and study completion dates: Oct 2030 to Jul 30, 2029 Primary endpoints: 1 to 2 · Enrollment target: 180 to 174 · Eligibility criteria expanded, about 53 words · 1 morev15 Show 4 more changesShow less
    • Primary endpoints: 1 to 2
    • Enrollment target: 180 to 174
    • Eligibility criteria expanded, about 53 words
    • Secondary endpoints: 15 to 30

    See this version in full on ClinicalTrials.gov ↗

  2. 2 versions Re-verified since Apr 10, 2024, no change to tracked fieldsv13-v14
  3. Study sites: 31 to 32v12
  4. Study sites: 30 to 31v11
  5. Study sites: 26 to 30v10
  6. Study sites: 25 to 26v9
  7. Study sites: 19 to 25v8
  8. Study sites: 13 to 19v7
  9. Study sites: 11 to 13v6
  10. Study sites: 8 to 11v5
  11. Study sites: 6 to 8v4
  12. Study sites: 3 to 6v3
  13. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 3 · Start date changed from estimate of Aug 2023 to Aug 11, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date changed from estimate of Aug 2023 to Aug 11, 2023
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 vanzacaftor/tezacaftor/deutivacaftor (VNZ/TEZ/D-IVA) in participants with cystic fibrosis (CF).
Trial Details
NCT Number NCT05844449
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Cystic Fibrosis
Enrollment 174 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov