Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID) - Full Text View

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00168012

Purpose

The purpose of this study is to demonstrate the effect of IVIG-F10 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 IVIG-F10 are studied.

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:	An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)

Further study details as provided by CSL Behring:

Primary Outcome Measures:

Proportion of infusions temporally (during the infusion and within 48 hours after the end of infusion) associated with one or more adverse events, regardless of relationship.

Secondary Outcome Measures:

Rate of acute serious bacterial infections
Number of days out of work/school due to underlying PID
Number of infections
Rate, severity and relationship of all adverse events

Estimated Enrollment:	42
Study Start Date:	September 2004
Study Completion Date:	September 2005

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
Regular IVIG therapy for at least 6 months prior to receiving IVIG-F10

Key Exclusion Criteria:

Allergic reactions to immunoglobulins or other blood products
Steroids (oral and parenteral, daily ≥0.15 mg of prednisone equivalent/kg/day
History of cardiac insufficiency
Epilepsia

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications of Results:

Berger M, Cunningham-Rundles C, Bonilla FA, Melamed I, Bichler J, Zenker O, Ballow M. Carimune NF Liquid is a safe and effective immunoglobulin replacement therapy in patients with primary immunodeficiency diseases. J Clin Immunol. 2007 Sep;27(5):503-9. Epub 2007 May 4.

Study ID Numbers:	ZLB04_005CR
Study First Received:	September 12, 2005
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00168012
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by CSL Behring:

Immunoglobulin intravenous
Agammaglobulinemia
Hypogammaglobulinemia

Common variable immunodeficiency
Immunoglobulin G
Children

Study placed in the following topic categories:

T cell immunodeficiency primary
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 16, 2009