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A Randomized, Multicenter, Open-label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients Without Inhibitors

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Trial Profile

A Randomized, Multicenter, Open-label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients Without Inhibitors

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Aug 2023

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At a glance

  • Drugs Emicizumab (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms HAVEN 3
  • Sponsors Chugai Pharmaceutical; Roche

    • Most Recent Events

    • 01 Jul 2023 Results (NCT03370913 and NCT02847637) Comparing bleeding outcomes of valoctocogene roxaparvovec gene therapy, emicizumab prophylaxis, and FVIII replacement prophylaxis in severe haemophilia A published in the Haemophilia
    • 01 Jun 2022 Status changed from active, no longer recruiting to completed.
    • 14 Dec 2021 Results of post hoc pooled analysis (n=504) assessing efficacy and safety of emicizumab in persons with hemophilia A aged greater than equal to 50 years with CV risk factors or HIV and/or HCV infection from HAVEN 1 (NCT02622321), 3 (NCT02847637), 4 (NCT03020160) and STASEY (NCT03191799) studies, presented at the 63rd American Society of Hematology Annual Meeting and Exposition.

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