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A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naive Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

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Trial Profile

A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naive Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jan 2024

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At a glance

  • Drugs Ravulizumab (Primary) ; Eculizumab
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Registrational; Therapeutic Use
  • Acronyms Study 301
  • Sponsors Alexion AstraZeneca Rare Disease

    • Most Recent Events

    • 01 Jan 2024 Results of post-hoc analysis assessing clinical outcomes and PROs from 246 complement inhibitor-naive patients with PNH , published in the Annals of Hematology.
    • 12 Dec 2023 Results reporting ravulizumab treatment outcomes for up to 6 years in patients with PNH from study 301 and comparing survival with untreated patients of the International PNH Registry (NCT01374360), presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 14 Jun 2023 This trial has been Completed in Poland, According to European Clinical Trials Database record.
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