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

Phase 3

Completed

• Conditions: IgG Deficiency; Common Variable Immunodeficiency; Agammaglobulinemia

• Registration Number: NCT00168012
• Lead Sponsor: CSL Behring

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study Completion: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate, severity and relationship of all adverse events
Number of days out of work/school due to underlying PID
Rate of acute serious bacterial infections
Number of infections