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FEIBA-GO

  • Research type

    Research Study

  • Full title

    FEIBA NF GLOBAL OUTCOME STUDY

  • IRAS ID

    164731

  • Contact name

    Senta Habenicht

  • Contact email

    senta_habenicht@baxter.com

  • Sponsor organisation

    Baxalta Innovations GmbH

  • Duration of Study in the UK

    5 years, 4 months, 29 days

  • Research summary

    The study addresses the need to measure long-term effectiveness, safety and quality of life outcome measures for haemophilia A or B patients with high-responding inhibitors treated on-demand and in prophylaxis with FEIBA NF [Anti-Inhibitor Coagulant Complex].
    The purpose of the study is to document the natural history of haemophilia A or B disease in subjects with high responding inhibitors either to Factor VIII or Factor IX and to describe long-term outcomes in terms of effectiveness, safety and quality of life in subjects receiving FEIBA NF in routine clinical practice.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    15/EM/0258

  • Date of REC Opinion

    31 Jul 2015

  • REC opinion

    Further Information Favourable Opinion