A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation

Trial Profile

A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation

Recruiting
Phase of Trial: Phase III

Latest Information Update: 30 Nov 2017

At a glance

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

    • 25 Oct 2017 According to a Vertex Pharmaceuticals media release, enrollment is complete in the 12 to 24 months age group in this trial.
    • 11 Sep 2017 New trial record
    • 10 Sep 2017 Planned End Date changed from 4 Jun 2021 to 7 Jun 2021.
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