Efficacy and Safety of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
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|ClinicalTrials.gov Identifier: NCT00168025|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency||Drug: Immunoglobulins Intravenous (Human)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||89 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Study on the Efficacy, Safety and Pharmacokinetics of IgPro10 in Patients With Primary Immunodeficiency (PID)|
|Study Start Date :||September 2004|
|Actual Study Completion Date :||March 2006|
|Experimental: IgPro10||Drug: Immunoglobulins Intravenous (Human)|
- Annualized rate of acute serious bacterial infections
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168025
|Study Director:||Program Director||CSL Behring|