Conditions: Common Variable Immunodeficiency Agammaglobulinemia
Keywords: Previously Untreated Patient (PUP) Primary Immunodeficiency (PID) CVID XLA Subcutaneous immunoglobulin (SCIG) IgG trough level Quality of life Common variable immunodeficiency (CVID) X-linked agammaglobulinemia (XLA)
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 18
Healthy volunteers: no

Brief summary:
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.

Detailed description:

Arms:
arm 1: Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.

Interventions: intervention 1: Vivaglobin
Intervention descriptions: intervention 1: Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.

Protocol document: