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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Oct 2017

At a glance

  • Drugs Hyaluronidase (Primary) ; Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Therapeutic Use
  • Sponsors Baxter Healthcare Corporation
  • Most Recent Events

    • 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.
    • 07 Mar 2016 Pooled analysis of 2 trials (n=63), including this extension and its parent trial [see CTP 700249878] 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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