Last updated on June 2016

An open-label, multi-center study to evaluate the safety and pharmacokinetics of IGSC 20% administered for 6 months in subjects with primary immunodeficiency


Brief description of study

An open-label, multi-center study to evaluate the safety and pharmacokinetics of IGSC 20% administered for 6 months in subjects with primary immunodeficiency

Detailed Study Description

Primary Immunodeficiency (PI) diseases are a family of congenital disorders of the immune system that lead to an increase in frequency of infections, notably, but not limited to, bacterial infections of the respiratory tract. Patients with PI do not have the healthy antibodies to fight off the infections and often are receiving immunoglobulin therapy to repair, stimulate, or enhance the body’s natural immune responses.

This study will look to compare the blood levels of Immune Globulin Injection (Human), 10% when it is given intravenously (IV, or in the vein) to the blood levels of IGSC 20% when it is given subcutaneously (SC, or under the skin) and to find out if IGSC 20% is safe when given to adults and children. IGIV-C 10%, has been approved for sale by the Food and Drug Administration (FDA), to be given as IV and subcutaneous injections.

Clinical Study Identifier: TX144033

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Jessica Trotter

University of South Florida-Morsani College of Medicine
St. Petersburg, FL USA
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