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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00168025
First received: September 12, 2005
Last updated: June 5, 2012
Last verified: June 2012

September 12, 2005
June 5, 2012
September 2004
Not Provided
Annualized rate of acute serious bacterial infections
Same as current
Complete list of historical versions of study NCT00168025 on ClinicalTrials.gov Archive Site
  • Number of infections
  • Number of days out of work / school due to underlying PID
  • Adverse events temporally associated with study drug infusion
  • Trough levels of total IgG serum concentrations
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Agammaglobulinemia
  • IgG Deficiency
  • Common Variable Immunodeficiency
Drug: Immunoglobulins Intravenous (Human)
Experimental: IgPro10
Intervention: Drug: Immunoglobulins Intravenous (Human)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
89
March 2006
Not Provided

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
Both
3 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00168025
ZLB03_002CR
Not Provided
CSL Behring
CSL Behring
Not Provided
Study Director: Program Director CSL Behring
CSL Behring
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP