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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00168025
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 6, 2012
Information provided by (Responsible Party):
CSL Behring

September 12, 2005
September 14, 2005
June 6, 2012
September 2004
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Annualized rate of acute serious bacterial infections
Same as current
Complete list of historical versions of study NCT00168025 on Archive Site
  • 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
Same as current
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Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

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.

Not Provided
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Agammaglobulinemia
  • IgG Deficiency
  • Common Variable Immunodeficiency
Drug: Immunoglobulins Intravenous (Human)
Experimental: IgPro10
Intervention: Drug: Immunoglobulins Intravenous (Human)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2006
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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
Sexes Eligible for Study: All
3 Years to 70 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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CSL Behring
CSL Behring
Not Provided
Study Director: Program Director CSL Behring
CSL Behring
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP