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A Multicenter, Open Label, Randomized, Parallel-group Study of Efficacy and Safety of Eculizumab (JSC GENERIUM, Russia) vs. Soliris® (Alexion Pharma GmbH, Switzerland) in Patients With Paroxysmal Nocturnal Hemoglobinuria

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A Multicenter, Open Label, Randomized, Parallel-group Study of Efficacy and Safety of Eculizumab (JSC GENERIUM, Russia) vs. Soliris® (Alexion Pharma GmbH, Switzerland) in Patients With Paroxysmal Nocturnal Hemoglobinuria

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Nov 2021

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At a glance

  • Drugs Eculizumab (Primary) ; Eculizumab
  • Indications Paroxysmal nocturnal haemoglobinuria
  • Focus Pharmacokinetics
  • Acronyms ECU-PNH-III

    • Most Recent Events

    • 01 Nov 2021 Primary endpoint of area under the LDH concentration-time curve (LDH AUC) during the maintenance therapy with the test drug or the reference drug has been met, according to Results published in the Annals of Hematology.
    • 01 Nov 2021 Results published in the Annals of Hematology
    • 15 Jul 2020 Since content, formulation and route of administration of of Elizaria (Biosimilar of Eculizumab) and Soliris is same, I am unable to add route of administration of Soliris due to database limitation. Please update further when more information is available.

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