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Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases

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Trial Profile

Efficacy, Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human), 10% (GAMMAGARD LIQUID/KIOVIG) Administered Intravenously or Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Jul 2022

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At a glance

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

    • Most Recent Events

    • 06 Jul 2022 According to a Takeda media release, based on four clinical trials(160602, 161101, 160603 and 160902) including this pivotal efficacy trial the Health Canada has issued the marketing authorization (Notice of Compliance) for HyQvia (Normal Immunoglobulin (Human) 10% & Recombinant Human Hyaluronidase solution for subcutaneous infusion) as replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult patients.
    • 07 Mar 2016 Pooled analysis of 2 trials (n=63), including this parent and its extension trial [see CTP 700265758] was presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
    • 07 Mar 2016 Results (pooled analysis of NCT00814320 and NCT01175213 studies (n = 63) assessing local adverse reaction rates) presented at the 2016 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
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