Agammaglobulinemia, Common Variable Immunodeficiency, IgG Deficiency
Conditions
Keywords
Immunoglobulin intravenous, Agammaglobulinemia, Hypogammaglobulinemia, Common variable immunodeficiency, Immunoglobulin G, Children
Brief summary
The purpose of this study is to demonstrate the effect of IVIG-F10 on the prevention of serious bacterial infections in patients with primary immunodeficiency. As secondary endpoints the rate of overall infections, the tolerability and safety of IVIG-F10 are studied.
Interventions
Sponsors
CSL Behring
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Patients with primary immunodeficiency * Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10 Key
Exclusion criteria
* Allergic reactions to immunoglobulins or other blood products * Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day * History of cardiac insufficiency * Epilepsia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship. | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of acute serious bacterial infections | — |
| Number of days out of work/school due to underlying PID | — |
| Number of infections | — |
| Rate, severity and relationship of all adverse events | — |
Outcome results
None listed