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

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ClinicalTrials.gov Identifier: NCT00168025
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 6, 2012
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
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


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

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 ClinicalTrials.gov identifier (NCT number): NCT00168025


Sponsors and Collaborators
CSL Behring
Investigators
Study Director: Program Director CSL Behring

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00168025     History of Changes
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
Agammaglobulinemia
Hypogammaglobulinemia
Common variable immunodeficiency
Immunoglobulin G
Children

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Common Variable Immunodeficiency
Agammaglobulinemia
IgG Deficiency
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Dysgammaglobulinemia
Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Immunologic Factors
Physiological Effects of Drugs