Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Sponsor

CSL Behring (Industry)

Overall Status

Completed

CT.gov ID

NCT00168025

Collaborator

(none)

Enrollment

Arm

17.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency	Drug: Immunoglobulins Intravenous (Human)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

Study Start Date :

Sep 1, 2004

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IgPro10	Drug: Immunoglobulins Intravenous (Human)

Arm

Intervention/Treatment

Experimental: IgPro10

Drug: Immunoglobulins Intravenous (Human)

Outcome Measures

Primary Outcome Measures

Annualized rate of acute serious bacterial infections []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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