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

This study has been completed.

First Received: September 12, 2005 Last Updated: October 22, 2008 History of Changes

Sponsor:	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

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)

Resource links provided by NLM:

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

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:

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 History of Changes
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

Additional relevant MeSH terms:

Agammaglobulinemia
Immunologic Factors
Immune System Diseases
Blood Protein Disorders
Hematologic Diseases
Physiological Effects of Drugs
Pharmacologic Actions
Immunologic Deficiency Syndromes
Lymphatic Diseases

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

ClinicalTrials.gov processed this record on November 30, 2009