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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Dec 2018

At a glance

  • Drugs Ravulizumab (Primary) ; Eculizumab
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Registrational; Therapeutic Use
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 21 Dec 2018 According to an Alexion Pharmaceuticals media release, based on comprehensive results from two phase 3 studies (NCT02946463 and NCT03056040), the U.S. FDA has approved ULTOMIRIS (ravulizumab-cwvz), administered every eight weeks, ahead of the PDUFA date of 18th Feb 2019, set by the FDA, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
    • 04 Dec 2018 Results characterizing ravulizumab pharmacokinetics (PK) and pharmacodynamics using two phase 3, randomized, open-label, noninferiority studies (NCT02946463, study 301; NCT030560040, study 302) presented at the 60th Annual Meeting and Exposition of the American Society of Hematology
    • 04 Dec 2018 Results from Prospective Analysis of Breakthrough Hemolysis in 2 Phase 3 Randomized Studies of Ravulizumab (ALXN1210) Versus Eculizumab study 301 and study 302, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology.
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