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Prospective open-label single-arm study of the pharmacokinetics and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency

Trial Profile

Prospective open-label single-arm study of the pharmacokinetics and safety of intravenous IgPro10 in Japanese subjects with primary immunodeficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jun 2021

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Pharmacokinetics
  • Sponsors CSL Behring
  • Most Recent Events

    • 01 Jun 2021 Results assessing the study evaluated safety and tolerability of IgPro10 in Japanese patients with primary immunodeficiency, published in the International Journal of Hematology.
    • 03 Jan 2020 The previously developed PPK model, containing IgG concentration data from 5 non-Japanese studies, was supplemented with data from 3 Japanese studies of IgPro10 or IgPro20 to compare the IgG PK parameters between Japanese and non-Japanese patients; results published in the Clinical Therapeutics
    • 01 Feb 2017 New trial record
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