A Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 ≥40% Predicted

Trial Profile

A Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 ≥40% Predicted

Completed
Phase of Trial: Phase II

Latest Information Update: 05 Feb 2016

At a glance

  • Drugs Ivacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Proof of concept; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 05 Feb 2016 According to Vertex media release, company has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for the use of KALYDECO (ivacaftor) in people with cystic fibrosis (CF). The FDA determined that it cannot approve the application in its present form. Vertex plans to meet with the FDA to determine an appropriate path forward.
    • 04 Jun 2014 Status changed from active, no longer recruiting to completed according to a Vertex Pharmaceuticals media release.
    • 04 Jun 2014 Primary endpoint 'Forced expiratory volume in 1 second (Change from baseline at 2 weeks)' has been met according to a Vertex Pharmaceuticals media release.
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