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Phase 4, Single-Arm Study of Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab

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Trial Profile

Phase 4, Single-Arm Study of Ravulizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria Currently Treated With High-Dose Eculizumab

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 09 Sep 2024

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At a glance

  • Drugs Eculizumab (Primary) ; Ravulizumab (Primary)
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Therapeutic Use
  • Acronyms ALXN1210-PNH-401; Study 401
  • Sponsors Alexion AstraZeneca Rare Disease

    • Most Recent Events

    • 20 Jan 2023 Status changed from active, no longer recruiting to completed.
    • 13 Dec 2022 Interim Results(n=10, up to day 183 of follow-up) assessing the impact of switching treatment from fixed, high-dose IV eculizumab (1200 mg q2w) to weight-based IV ravulizumab q8w in patients with paroxysmal nocturnal hemoglobinuria presented at the 64th American Society of Hematology Annual Meeting and Exposition
    • 21 Sep 2021 Planned End Date changed from 1 Nov 2022 to 30 Nov 2022.

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