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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Aug 2017

At a glance

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

    • 08 Aug 2017 Planned number of patients changed from 126 to 90.
    • 16 May 2017 New trial record
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