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

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2017

At a glance

  • Drugs Ivacaftor (Primary) ; Ivacaftor/tezacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals
  • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top