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 IgPro10 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 IgPro10 are studied. A part of the patients are participating in a pharmacokinetic substudy.
Interventions
Sponsors
CSL Behring
Study design
Allocation
NA
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 * Patients who have received stable IVIG therapy at 3- or 4-weekly intervals for at least 6 months Key
Exclusion criteria
* Newly diagnosed PID * Allergic reactions to immunoglobulins or other blood products * Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs * Concomitant diseases such as hypoalbuminemia, protein-losing enteropathies, kidney diseases with proteinuria, malignancies of lymphoid cells (e.g. lymphocytic leukemia), and recent history of migraine * History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualized rate of acute serious bacterial infections | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of infections | — |
| Number of days out of work / school due to underlying PID | — |
| Adverse events temporally associated with study drug infusion | — |
| Trough levels of total IgG serum concentrations | — |
Outcome results
None listed