Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID) - Full Text View

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00168025

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 III

Genetics Home Reference related topics: aceruloplasminemia X-linked agammaglobulinemia X-linked hyper IgM syndrome

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

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

Estimated Enrollment:	88
Study Start Date:	September 2004

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

No Contacts or Locations Provided

More Information

Publications of Results:

Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J; for the IgPro10 in PID study group. Safety and Efficacy of Privigen(R), a Novel 10% Liquid Immunoglobulin Preparation for Intravenous Use, in Patients with Primary Immunodeficiencies. J Clin Immunol. 2008 Sep 24; [Epub ahead of print]

Study ID Numbers:	ZLB03_002CR
Study First Received:	September 12, 2005
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00168025
Health Authority:	United States: Food and Drug Administration; Belgium: Directorate general for the protection of Public health: Medicines; 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

Study placed in the following topic categories:

Agammaglobulinemia
Common variable immunodeficiency
Blood Protein Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Lymphatic Diseases
Antibodies

Immunoglobulins, Intravenous
Immunoglobulin G
IgG Deficiency
Rho(D) Immune Globulin
Lymphoproliferative Disorders
Common Variable Immunodeficiency
Immunoglobulins

Additional relevant MeSH terms:

Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Dysgammaglobulinemia
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009