A Phase 2, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label Extension

Trial Profile

A Phase 2, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label Extension

Completed
Phase of Trial: Phase II

Latest Information Update: 14 Jun 2017

At a glance

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

    • 15 Aug 2016 Status changed from active, no longer recruiting to completed.
    • 23 Mar 2015 Results published in Vertex Pharmaceuticals media release.
    • 11 Jan 2015 According to a Vertex Pharmaceuticals media release, 12-week data from this study are expected in the first quarter of 2015.
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