A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex 10 and Gammaplex 5% in Primary Immunodeficiency Diseases

Trial Profile

A Phase III, Multicenter, Open-label, Randomized, Two-Period, Crossover Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex 10 and Gammaplex 5% in Primary Immunodeficiency Diseases

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2017

At a glance

  • Drugs Immune globulin (Primary)
  • Indications Common variable immunodeficiency; Hyperimmunoglobulinaemia
  • Focus Pharmacokinetics; Registrational
  • Sponsors Bio Products Laboratory
  • Most Recent Events

    • 06 Mar 2017 Results presented at the 2017 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 07 Feb 2017 According to Bio Products Laboratory media release, FDA approves Bio Products Laboratory's Gammaplex 10% for treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura.
    • 11 May 2016 Status changed from recruiting to completed.
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