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An Open-label, Multi-center Study to Evaluate the Safety and Pharmacokinetics of IGSC 20% Administered for 6 Months in Subjects With Primary Immunodeficiency

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Trial Profile

An Open-label, Multi-center Study to Evaluate the Safety and Pharmacokinetics of IGSC 20% Administered for 6 Months in Subjects With Primary Immunodeficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2022

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At a glance

  • Drugs Immune globulin (Primary) ; Immune globulin
  • Indications Agammaglobulinaemia; Primary immunodeficiency diseases
  • Focus Pharmacokinetics
  • Sponsors Grifols

Most Recent Events

  • 01 Mar 2022 Results of pharmacokinetic modeling and simulation of subcutaneous and intravenous IgG dosing by using data from three studies including this study published in the International Immunopharmacology
  • 16 Mar 2020 Results presented on 2020 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
  • 16 Mar 2020 Results assesseing the safety and tolerability of IGSC-C 20% and intravenous immune globulin infusion (human),10% caprylate/ chromatography purified (IGIV-C 10%) in participants with PI, presented at the 2020 Annual Meeting of the American Academy of Allergy, Asthma and Immunology

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