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

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Trial Profile

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

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; Normal human immunoglobulin; Normal human immunoglobulin
  • Indications Immunodeficiency disorders
  • Focus Therapeutic Use
  • Sponsors Baxter BioScience; Baxter Innovations GmbH

    • 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 NCT01218438 and NCT04346108 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
    • 06 Mar 2017 Results assessing treatment satisfaction in patients from two phase 2/3 studies (European study and North American study) presented at the 2017 Annual Meeting of the American Academy of Allergy, Asthma and Immunology

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