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

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

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Nov 2017

At a glance

  • Drugs Immune globulin (Primary) ; Immune globulin (Primary) ; Hyaluronidase
  • Indications Immunodeficiency disorders
  • Focus Adverse reactions; Registrational
  • Sponsors Baxalta; Baxter Healthcare Corporation
  • Most Recent Events

    • 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.
    • 02 Dec 2015 Protocol has been amended in change of time fame of primary endpoint from 1 year to 17 months.
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