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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

Most Recent Events

  • 25 Oct 2017 Based on the results from this study, Vertex does not plan to seek regulatory approval for the tezacaftor/ivacaftor combination in people with CF ages 12 and older with one copy of the F508del mutation and one copy of a gating mutation, according to a company media release.
  • 25 Oct 2017 Primary endpoint (Absolute change in percent predicted forced expiratory volume in 1 second (FEV1)) has not been met, according to a Vertex Pharmaceuticals media release.
  • 19 Oct 2017 Status changed from active, no longer recruiting to completed.

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