Safety in PI (primary immunodeficiency disease) - Study design
A prospective, open-label, single-arm, multicenter, phase III study in PI¹
- 50 patients were enrolled who had been receiving IGIV replacement therapy every 3 to 4 weeks for at least 3 months prior to the start of the study
- Patients received Gammaplex at individually adjusted doses ranging from 279 mg/kg to 799 mg/kg for 12 months
- Infusions were started at a rate of 0.01 mL/kg/min and could be gradually increased up to a defined maximum rate of 0.08 mL/kg/min every fifteen minutes.
- A total of 703 infusions were administered
The most common adverse reactions were headache, fatigue, nausea, pyrexia, pain, hypertension, chills, myalgia and vomiting.
Safety of Gammaplex in chronic ITP (immune thrombocytopenic purpura) - Study design
A prospective, open-label, single-arm, multicenter study assessed the safety of Gammaplex in chronic ITP2.
The study was performed in 35 subjects with chronic ITP
- Each subject had a platelet count of ≤20 x 109/L
- 9 subjects were male and 26 were female
- Patients received a cumulative 2 g/kg dose of Gammaplex administered as 1 g/kg/day for two consecutive days
- Subjects were observed for 90 days
The most common adverse reactions were headache, vomiting, nausea, pyrexia, pruritus, dehydration and arthralgia.
1. Moy J N, Scharenberg AM, Stein MR, et al. Efficacy and safety of a new immunodeficiency disease. Clin Exp Immunol 2010; 162: 510-515.
2. Gammaplex Prescribing Information, 2014 VSUS5PI