Decision: Favourable

Study Title:

A Phase 3 open-label, multicenter study of the long-term safety and efficacy of intravenous recombinant coagulation  factor VIII Fc-von willebrand factor-XTEN fusion protein (rFVIIIFc-VWF-XTEN? BIVV001) in previously treated patients with severe hemophili

  • NREC Code:

    22-NREC-CT-084

  • Decision:

    Favourable

  • Meeting Date:

    27/04/2022

  • Study Type:

    CT application

  • Principal Investigator:

    Prof. Beatrice Nolan

  • PI Institution:

    CHI Crumlin

  • Sponsor:

    Sanofi

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