- * Written informed consent, age-adapted
- * Male or female aged 1 to 70 years
- * Diagnosis of primary humoral immunodeficiency
- * No prior immunoglobulin substitution therapy
- * IgG level of \<5 g/L at screening
- * Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening
- Key
Common Variable Immunodeficiency
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.
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Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov