Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR Mutation

Trial Profile

Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR Mutation

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 25 Jul 2018

At a glance

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

    • 18 Jul 2018 Planned End Date changed from 30 Jun 2018 to 1 Aug 2018.
    • 18 Jul 2018 Planned primary completion date changed from 30 Jun 2018 to 1 Aug 2018.
    • 18 Jul 2018 Status changed from recruiting to active, no longer recruiting.
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