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A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A

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Trial Profile

A Phase II/III, Multicenter, Partially Randomized, Open Label Trial Investigating Safety and Efficacy of On-demand and Prophylactic Treatment With BAY94-9027 in Severe Hemophilia A

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 09 Nov 2023

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At a glance

  • Drugs Damoctocog alfa pegol (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms PROTECT VIII extension; PROTECT-VIII
  • Sponsors Bayer; Bayer HealthCare

Most Recent Events

  • 31 Oct 2023 According to Octapharma media release, data from the study were presented in the European Journal of Haematology.
  • 31 Oct 2023 Results of Indirect comparison from a matching-adjusted indirect comparison (MAIC) of Nuwiq (simoctocog alfa) versus extended half-life recombinant factor VIII (rFVIII) concentrates in haemophilia A patients undergoing personalised prophylaxis published in the Media Release
  • 13 Dec 2022 Results comparing the efficacy of personalized prophylaxis with simoctocog alfa with three comparator FVIII products - efmoroctocog alfa, damoctocog alfa pegol and rurioctocog alfa pegol in the patients from NuPreviq, A-LONG, PROTECT VIII and PROPEL studies presented at the 64th American Society of Hematology Annual Meeting and Exposition.

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