Overview

Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)

Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CSL Behring
Treatments:
Antibodies
Immunoglobulins
Immunoglobulins, Intravenous
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