VX11-770-109 Roll-Over Study Paediatric CF CFTR gating mutation

  • Research type

    Research Study

  • Full title

    A Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation

  • IRAS ID

    131110

  • Contact name

    Jane Davies

  • Contact email

    j.c.davies@imperial.ac.uk

  • Sponsor organisation

    Vertex Pharmaceuticals Incorporated

  • Eudract number

    2012-000386-20

  • ISRCTN Number

    n/a

  • Clinicaltrials.gov Identifier

    n/a

  • REC name

    East Midlands - Nottingham 2 Research Ethics Committee

  • REC reference

    13/EM/0268

  • Date of REC Opinion

    31 Jul 2013

  • REC opinion

    Favourable Opinion