A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Trial Profile

A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Ivacaftor (Primary) ; Lumacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Adverse reactions; Registrational
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 09 Aug 2017 Planned number of patients changed from 245 to 240.
    • 09 Aug 2017 Status changed from recruiting to active, no longer recruiting.
    • 10 Jun 2017 Biomarkers information updated
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