Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)

Common Variable Immunodeficiency Clinical Trial

Official title:

A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00168025
• Other study ID #: ZLB03_002CR
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: June 5, 2012
• Start date: September 2004
• Est. completion date: March 2006

Study information

• Verified date: June 2012
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicines and Health Products, FAMHPSwitzerland: SwissmedicGermany: Paul-Ehrlich-InstitutFrance: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Agammaglobulinemia
• Common Variable Immunodeficiency
• IgG Deficiency
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Immunoglobulins Intravenous (Human)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

References & Publications (2)

Sleasman JW, Duff CM, Dunaway T, Rojavin MA, Stein MR. Tolerability of a new 10% liquid immunoglobulin for intravenous use, Privigen, at different infusion rates. J Clin Immunol. 2010 May;30(3):442-8. doi: 10.1007/s10875-010-9373-x. Epub 2010 Mar 10. — View Citation

Stein MR, Nelson RP, Church JA, Wasserman RL, Borte M, Vermylen C, Bichler J; IgPro10 in PID study group. Safety and efficacy of Privigen, a novel 10% liquid immunoglobulin preparation for intravenous use, in patients with primary immunodeficiencies. J Cl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized rate of acute serious bacterial infections
Secondary	Number of infections
Secondary	Number of days out of work / school due to underlying PID
Secondary	Adverse events temporally associated with study drug infusion
Secondary	Trough levels of total IgG serum concentrations

External Links

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