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A MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF SUBCUTANEOUS ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIATRIC PATIENTS WITH INHIBITORS

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Trial Profile

A MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF SUBCUTANEOUS ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIATRIC PATIENTS WITH INHIBITORS

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2024

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At a glance

  • Drugs Emicizumab (Primary)
  • Indications Haemophilia A
  • Focus Registrational; Therapeutic Use
  • Acronyms HAVEN 2
  • Sponsors Chugai Pharmaceutical; Roche

Most Recent Events

  • 12 Dec 2023 Results assessing rationale and treatment decisions regarding initiation of emicizumab prophylaxis in children under 12 months of age among pediatric HTC, presented at the 65th American Society of Hematology Annual Meeting and Exposition
  • 03 Dec 2021 Data from this study used to assess cost-effectiveness of emicizumab prophylaxis therapy and rFVIIa on-demand therapy for HA patients with inhibitors in China the 24th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
  • 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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