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

CSL Behring

Status and phase: Completed; Phase 3

Conditions: Common Variable Immunodeficiency; Agammaglobulinemia; IgG Deficiency

Treatments: Drug: Immunoglobulins Intravenous (Human)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00168012

ZLB04_005CR

Details and patient eligibility

About

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.

Sex: All

Ages: 3 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)