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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00168025
First received: September 12, 2005
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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)

  Eligibility

Ages Eligible for Study:   3 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168025

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

Additional Information:
Click here to request more information about this study  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00168025     History of Changes
Other Study ID Numbers: ZLB03_002CR
Study First Received: September 12, 2005
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Switzerland: Swissmedic
Germany: Paul-Ehrlich-Institut
France: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on June 18, 2013