Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency Diseases

Trial Profile

Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency Diseases

Completed
Phase of Trial: Phase II/III

Latest Information Update: 27 Nov 2017

At a glance

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

    • 16 Nov 2016 According to a Shire media release, based on the data from this and another phase III study (profile 278874), the U.S. Food and Drug Administration (FDA) has approved CUVITRU in September 2016 as a subcutaneous immune globulin (IG) replacement therapy for primary immunodeficiency.
    • 10 Jun 2016 According to a Shire media release, the company expects a regulatory decision for Cuvitru in the US later in 2016.
    • 15 Sep 2015 According to Baxalta media release, company has submitted to the US FDA for approval of IGSC 20%.
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