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
Phase of Trial: Phase III
Latest Information Update: 04 Apr 2017
At a glance
- Drugs Immune globulin (Primary)
- Indications Common variable immunodeficiency; Hyperimmunoglobulinaemia; Immunodeficiency disorders
- Focus Pharmacokinetics; Registrational
- Sponsors Bio Products Laboratory
- 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.