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A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)

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Trial Profile

A Clinical Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) for the Evaluation of Efficacy, Safety, Tolerability and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases (PIDD)

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 26 Sep 2023

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At a glance

  • Drugs Immune globulin (Primary) ; Immune globulin
  • Indications Immunodeficiency disorders
  • Focus Therapeutic Use
  • Sponsors Baxalta; Baxter Healthcare Corporation

    • Most Recent Events

    • 25 Sep 2023 According to Takeda media release, the Japanese Ministry of Health, Labour and Welfare has approved the use of CUVITRU subcutaneous Ig in Japan for patients with agammaglobulinemia or hypogammaglobulinemia, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency or secondary immunodeficiency, based on the results of this trail along with results of NCT04346108 and NCT01412385 studies respectively.
    • 16 Mar 2020 Results of a retrospective analysis from two Phase 2/3 studies (North American [NCT01218438] and European [NCT01412385]) published on 2020 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 19 Jun 2019 Results of post-hoc analysis of tolerability wit Ig20Gly therapy after switching from previous therapy in patients with primary immunodeficiency diseases, published in the Annals of Allergy, Asthma and Immunology

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