A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation

Trial Profile

A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Feb 2017

At a glance

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

    • 02 Dec 2016 Planned End Date changed from 1 Mar 2017 to 1 Sep 2018.
    • 02 Dec 2016 Planned primary completion date changed from 1 Mar 2017 to 1 Sep 2018.
    • 09 Nov 2016 New trial record
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