A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive

Trial Profile

A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2017

At a glance

  • Drugs Ivacaftor (Primary) ; Ivacaftor/tezacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 08 Aug 2017 Planned End Date changed from 1 Dec 2017 to 1 Sep 2017.
    • 08 Aug 2017 Planned primary completion date changed from 1 Nov 2017 to 1 Sep 2017.
    • 26 Jul 2017 Data from this study are expected in the second half of 2017 according to a Vertex Pharmaceuticals media release.
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