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A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID)

Trial Profile

A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2021

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Agammaglobulinaemia; Common variable immunodeficiency; Immunodeficiency disorders
  • Focus Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors CSL Behring

Most Recent Events

  • 14 Jan 2020 New trial record
  • 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

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