Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency
Status:
Completed
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
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.