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A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients

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Trial Profile

A Phase III, Open-label, Prospective, Multicenter Study to Assess Efficacy, Safety and Pharmacokinetics of Kedrion Intravenous Immunoglobulin (IVIg) 10% in Primary Immunodeficiency Disease (PID) Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Dec 2022

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Agammaglobulinaemia; Immunodeficiency disorders
  • Focus Registrational; Therapeutic Use
  • Acronyms CARES10
  • Sponsors Kedrion

    • Most Recent Events

    • 14 Nov 2022 Results of novel glycine stabilized 10% Ig preparation for IV administration in patients with PIDD and evaluate its safety and pharmacokinetics, presented at the 2022 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology.
    • 06 May 2021 Status changed from active, no longer recruiting to completed.
    • 04 Jan 2021 According to an Kedrion Biopharma media release, last patient has been treated in this trial.

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