A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have a CFTR Gating Mutation

Trial Profile

A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have a CFTR Gating Mutation

Recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2017

At a glance

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

    • 06 Oct 2016 Planned number of patients changed from 30 to 35.
    • 27 Apr 2016 Status changed from planning to recruiting, as per Vertex media release.
    • 21 Oct 2015 New trial record
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