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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 05 Jul 2025

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Primary immunodeficiency diseases
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Baxter Healthcare Corporation

Most Recent Events

  • 30 Jun 2025 According to a Takeda media release, the company has received approval from the U.S. Food and Drug Administration (FDA) and EU for ready-to-use liquid formulation (GAMMAGARD LIQUID ERC) for patients and their health care providers by eliminating the need for reconstitution and can be administered intravenously or subcutaneously based on studies conducted for GAMMAGARD LIQUID.
  • 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 .

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