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Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

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Trial Profile

Extension Study for Patients Who Completed GENA-05 (NuProtect)- to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2023

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At a glance

  • Drugs Simoctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Pharmacodynamics; Registrational
  • Acronyms NuProtect-Extension study
  • Sponsors Octapharma
  • Most Recent Events

    • 01 Jul 2023 Results reporting data on long-term immunogenicity, efficacy and tolerability of simoctocog alfa in patients with severe haemophilia A published in the Haemophilia
    • 08 Dec 2020 Results presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
    • 13 Jul 2020 According to an Octapharma media release, results from this study will be presented at the upcoming International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress, 2020.

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