A Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Trial Profile

A Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

Completed
Phase of Trial: Phase II

Latest Information Update: 20 Sep 2017

At a glance

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

    • 20 Sep 2017 Results (n=190) assessing safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of VX-661 alone or in combination with ivacaftor (VX-770) for the treatment of patients with cystic fibrosis and either a homozygous or heterozygous F508del-CFTR mutation, were published in the American Journal of Respiratory and Critical Care Medicine
    • 07 Apr 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
    • 25 Oct 2013 Planned End Date changed from 1 Aug 2013 to 1 Mar 2014 as reported by ClinicalTrials.gov.
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