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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: 31 Dec 2024

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At a glance

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

Most Recent Events

  • 27 Dec 2024 According to a Takeda media release, company announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of HYQVIA in patients with agammaglobulinemia or hypogammaglobulinemia based on the data of NCT05150340, NCT05513586, NCT00814320 and NCT01175213 studies.
  • 21 Jun 2024 According to a Takeda media release, company announce that Health Canada has expanded the marketing authorization (NOC) for HyQvia (normal immunoglobulin [human] 10% and recombinant human hyaluronidase solution for subcutaneous infusion) as a replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in pediatric patients 2 years of age and older. Authorization was based on two pivotal studies in 66 patients ranging in age from 2 to 16 years.
  • 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.

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