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
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
- 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