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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

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

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Study Type : Interventional  (Clinical Trial)
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 : September 2004
Actual Study Completion Date : March 2006

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

Primary Outcome Measures :
  1. Annualized rate of acute serious bacterial infections

Secondary Outcome Measures :
  1. Number of infections
  2. Number of days out of work / school due to underlying PID
  3. Adverse events temporally associated with study drug infusion
  4. Trough levels of total IgG serum concentrations

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00168025

Sponsors and Collaborators
CSL Behring
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Study Director: Program Director CSL Behring
Additional Information:
Publications of Results:
Other Publications:
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Responsible Party: CSL Behring Identifier: NCT00168025    
Other Study ID Numbers: ZLB03_002CR
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: June 6, 2012
Last Verified: June 2012
Keywords provided by CSL Behring:
Immunoglobulin Intravenous
Common variable immunodeficiency
Immunoglobulin G
Additional relevant MeSH terms:
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IgG Deficiency
Immunologic Deficiency Syndromes
Common Variable Immunodeficiency
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs