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Prospective, Open-label, Multicenter Phase 3b Study to Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A

Trial Profile

Prospective, Open-label, Multicenter Phase 3b Study to Assess the Safety and Efficacy of Individually Tailored Prophylaxis With Human-cl rhFVIII in Previously Treated Adult Patients With Severe Haemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2019

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At a glance

  • Drugs Simoctocog alfa (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms NuPreviq
  • Sponsors Octapharma
  • Most Recent Events

    • 30 Sep 2019 According to an Octapharma media release, based on the data from this study, the European Medicines Agency has authorised an updated Summary of Product Characteristics (SmPC) for Nuwiq that includes information on personalised prophylaxis in patients with haemophilia A.
    • 08 Jul 2019 Results presented in an Octapharma Media Release.
    • 22 May 2017 Results published online in April 2017 as an Early View Article in the medical journal Haemophilia, according to an Octapharma media release.
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