BAY 94-9027 pediatric pharmacokinetics, safety, and efficacy trial

  • Research type

    Research Study

  • Full title

    A multi-center, phase III, non-controlled, open-label trial to evaluate the pharmacokinetics, safety, and efficacy of BAY 94-9027 for prophylaxis and treatment of bleeding in previously treated children (age <12 years) with severe hemophilia A

  • IRAS ID

    120422

  • Contact name

    Tina Biss

  • Contact email

    Tina.biss@nuth.nhs.uk

  • Sponsor organisation

    Bayer plc

  • Eudract number

    2012-004434-42

  • ISRCTN Number

    N/A

  • REC name

    North East - Tyne & Wear South Research Ethics Committee

  • REC reference

    13/NE/0049

  • Date of REC Opinion

    15 Apr 2013

  • REC opinion

    Further Information Favourable Opinion