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Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older

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

Record History

  1. Re-verified, no change to tracked fieldsv9
  2. Trial status: Enrolling by Invitation to Active, Not Recruitingv8
  3. Study sites: 17 to 18v7
  4. Study sites: 13 to 17v6
  5. Study sites: 10 to 13v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 5 to 10 Primary and study completion dates: Sep 2027 to Sep 30, 2027v4 Show 1 more changeShow less
    • Primary and study completion dates: Sep 2027 to Sep 30, 2027
  2. Study sites: 1 to 5v3
  3. Trial status: Not Yet Recruiting to Enrolling by Invitation Study sites: 0 to 1 · Start date changed from estimate of Oct 2024 to Nov 21, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Oct 2024 to Nov 21, 2024
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
Trial Details
NCT Number NCT06460506
Lead Sponsor Vertex Pharmaceuticals Incorporated
Conditions Cystic Fibrosis
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov