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A Phase IIIb, Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Patients From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

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Trial Profile

A Phase IIIb, Multicenter, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Patients From Birth to 12 Months of Age With Hemophilia A Without Inhibitors

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Feb 2025

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At a glance

  • Drugs Emicizumab (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms HAVEN 7
  • Sponsors Roche

    • Most Recent Events

    • 05 Nov 2024 According to Roche media release, company will present data of this trial at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held 7-10 December 2024 in San Diego, US.
    • 12 Dec 2023 Results (cut-off date :May 22, 2023,n=55) Primary Analysis evaluating the efficacy, safety, and pharmacokinetics (PK) of emicizumab in infants upto 12 months of age with severe HA without FVIII inhibitors, presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 12 Dec 2023 Results(data cut-off May 22, 2023 n=55)assessing Pharmacodynamic biomarkers and FIX and FX plasma levels in during the first 52 weeks of emicizumab exposure , presented at the 65th American Society of Hematology Annual Meeting and Exposition

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