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A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

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Trial Profile

A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs Ivacaftor/lumacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Registrational
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 19 Oct 2023 Planned number of patients changed from 50 to 52.
  • 20 Sep 2023 Status changed from active, no longer recruiting to completed.
  • 26 Nov 2021 Status changed from recruiting to active, no longer recruiting.

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