An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

Trial Profile

An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) GC5107 in Subjects With Primary Humoral Immunodeficiency

Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Dec 2016

At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Green Cross
  • Most Recent Events

    • 25 Oct 2016 Planned primary completion date changed from 1 Oct 2017 to 1 Jan 2018.
    • 25 Oct 2016 Status changed from not yet recruiting to recruiting.
    • 10 Mar 2016 New trial record
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