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Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII in Previously Untreated Patients with Severe Haemophilia A

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Trial Profile

Immunogenicity, Efficacy and Safety of Treatment with Human-cl rhFVIII in Previously Untreated Patients with Severe Haemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jan 2024

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At a glance

  • Drugs Simoctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Pharmacodynamics; Registrational
  • Acronyms NuProtect; NuProtect PUP
  • Sponsors Octapharma

    • Most Recent Events

    • 12 Dec 2023 Results assessing peripheral blood transcriptomic profiles prior to and during early FVIII treatment in severe hemophilia A patients who did or did not develop inhibitors to simoctocog alfa, presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 27 Nov 2023 According to an Octapharma media release, researchers from University College London, UK, will present new data from a sub-study of the NuProtect study, revealing differences in gene expression profiles between PUPs who developed inhibitors and those who did not at the at the 65th American Society of Hematology (ASH) Meeting and Exposition.
    • 01 Oct 2023 Final results from NuProtect study assessing safety and efficacy published in the European Journal of Haematology.
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