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A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks (Q4W) in Patients With Hemophilia A

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Trial Profile

A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks (Q4W) in Patients With Hemophilia A

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2023

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At a glance

  • Drugs Emicizumab (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms HAVEN 4
  • Sponsors Chugai Pharmaceutical; Roche; Roche Farma

    • Most Recent Events

    • 25 Jul 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.
    • 01 Nov 2021 Results assessing immunogenicity of emicizumab in seven phase 3/3b clinical studies (HAVEN 1-5, HOHOEMI and STASEY) in persons with haemophilia A, published in the Haemophilia.

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