A Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and Adolescents

Trial Profile

A Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and Adolescents

Completed
Phase of Trial: Phase IV

Latest Information Update: 01 May 2016

At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Adverse reactions
  • Sponsors Bio Products Laboratory
  • Most Recent Events

    • 06 Aug 2015 According to Bio Products Laboratory media release, Gammaplex has been approved for pediatric patients (2 years and older) with primary humoral immunodeficiencies by the US FDA. The approval was based on results from this trial.
    • 06 Aug 2015 Results published in the Media Release.
    • 18 Jun 2014 New trial record
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