Safety and Efficacy 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:	NCT00322556

Purpose

The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety, the number of infusions temporally associated with AEs, the rate, severity and relationship of all AEs and the vital sign changes during each infusion will be evaluated.

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

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 Extension Study on the Safety and Efficacy of IgPro10 in Patients With Primary Immunodeficiency (PID)

Further study details as provided by CSL Behring:

Primary Outcome Measures:

Safety endpoints: The proportion of infusions temporally (during infusion and within 48 hours after the end of infusion) associated with one or more AEs [ Time Frame: Will be recoreded as they occur during study ] [ Designated as safety issue: Yes ]
Influence of infusion rate on adverse events [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Rate, severity and relationship of all AEs [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Vital sign changes during each infusion [ Time Frame: Every 3 or 4 weeks depending on dosing schedule ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Efficacy endpoints: Rate of acute serious bacterial infections; [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Number of days out of work / school / kindergarten / day care due to underlying PID [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Number of days of hospitalization [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Rate of any infections [ Time Frame: Will be recorded as they occur during study ] [ Designated as safety issue: Yes ]
Trough levels of total IgG serum concentrations [ Time Frame: Every three or four weeks depending on dosing schedule prior to infusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	November 2005
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw

Eligibility

Ages Eligible for Study:	4 Years to 71 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who have participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03_002CR) at 3- or 4- weekly intervals for 12 months
Written informed consent

Key Exclusion Criteria:

Diagnosis of epilepsia
Insulin dependent diabetes
Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
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: NCT00322556

Locations

United States, Indiana

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

CSL Behring

More Information

Responsible Party:	CSL Behring ( Christian Peters, MD, PhD )
Study ID Numbers:	ZLB05_006CR
Study First Received:	May 5, 2006
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00322556
Health Authority:	United States: Food and Drug Administration

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 16, 2009