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Long-Term Tolerability and Safety of Immune Globulin Subcutaneous (IGSC) Solution Administered Subcutaneously Following Administration of Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Primary Immunodeficiency Diseases

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Trial Profile

Long-Term Tolerability and Safety of Immune Globulin Subcutaneous (IGSC) Solution Administered 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
  • Focus Therapeutic Use
  • Sponsors 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.
  • 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.
  • 24 May 2016 Trial focus changed from safety to efficacy, Intravenous route of administration has been added to treatments, time frame for primary endpoint changed from 21 months to 729 days, primary endpoints added.

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