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: 26 Feb 2018

At a glance

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

    • 11 Jan 2018 Baxalta merged with Shire in Jun 3, 2016.
    • 11 Jan 2018 Baxalta is the former Baxter BioScience global biopharmaceutical business spun off in July of 2015 by Baxter International with a focus on developing new treatments for people with orphan diseases and underserved conditions in three areas of therapeutic focus .
    • 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.
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