Study of BPL's FX in FX deficient patients requiring surgery Version 1

  • Research type

    Research Study

  • Full title

    A Phase III Open, Multicentre Study to Investigate the Safety and Efficacy of BPL’s High Purity FACTOR X in the Treatment of Factor X Deficient Subjects Undergoing Surgery

  • IRAS ID

    41663

  • Contact name

    Michael Makris

  • Sponsor organisation

    Bio Products Laboratory

  • Eudract number

    2009-015086-31

  • ISRCTN Number

    N/A

  • Research summary

    Factor X is being developed as a treatment for participants with a deficiency in clotting Factor X. The purpose of this study is to look at how well Factor X works at preventing excessive blood loss during and after surgery. Finally the study will look at how safe Factor X is by closely following the paticipants progress during the study.

  • REC name

    Yorkshire & The Humber - Leeds East Research Ethics Committee

  • REC reference

    10/H1306/5

  • Date of REC Opinion

    16 Mar 2010

  • REC opinion

    Further Information Favourable Opinion