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