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

This study has been completed.
Information provided by (Responsible Party):
CSL Behring Identifier:
First received: September 12, 2005
Last updated: June 5, 2012
Last verified: June 2012

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 Intervention Phase
Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency Drug: Immunoglobulins Intravenous (Human) Phase 3

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:

Further study details as provided by CSL Behring:

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

Enrollment: 89
Study Start Date: September 2004
Study Completion Date: March 2006
Arms Assigned Interventions
Experimental: IgPro10 Drug: Immunoglobulins Intravenous (Human)


Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00168025

Sponsors and Collaborators
CSL Behring
Study Director: Program Director CSL Behring
  More Information

Additional Information:
Responsible Party: CSL Behring Identifier: NCT00168025     History of Changes
Other Study ID Numbers: ZLB03_002CR
Study First Received: September 12, 2005
Last Updated: June 5, 2012

Keywords provided by CSL Behring:
Immunoglobulin Intravenous
Common variable immunodeficiency
Immunoglobulin G

Additional relevant MeSH terms:
Common Variable Immunodeficiency
Immunologic Deficiency Syndromes
IgG Deficiency
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs processed this record on September 20, 2017