Conditions: Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency
Keywords: Immunoglobulin Intravenous Agammaglobulinemia Hypogammaglobulinemia Common variable immunodeficiency Immunoglobulin G Children
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

Brief summary:
The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

Detailed description:

Arms:
arm 1: See Intervention Description

Interventions: intervention 1: Immunoglobulins Intravenous (Human)
Intervention descriptions: intervention 1: Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

Protocol document: