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

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

MedlinePlus related topics:

Bacterial Infections

ChemIDplus related topics:

Globulin, Immune Immunoglobulins

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
Estimated Study Completion Date:	January 2006

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

Study ID Numbers:	ZLB04_005CR
First Received:	September 12, 2005
Last Updated:	March 7, 2006
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

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 September 22, 2008

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