Efficacy and Safety of Intravenous Immunoglobulin IVIG-F10 in Patients With Primary Immunodeficiencies (PID)
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|ClinicalTrials.gov Identifier: NCT00168012|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : February 11, 2011
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 or disease||Intervention/treatment||Phase|
|Agammaglobulinemia IgG Deficiency Common Variable Immunodeficiency||Drug: Immunoglobulins Intravenous (Human)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Study to Evaluate the Safety and Efficacy of IVIG-F10 in Patients With Primary Immunodeficiency Diseases (PID)|
|Study Start Date :||September 2004|
|Actual Study Completion Date :||September 2005|
- 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.
- 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