The purpose of this research study is to determine the safety and outcome of treatment with an investigational immune globulin product: Immune Globulin Intravenous (Human) manufactured using chromatography as part of the purification process (IGIV-C, 10%) in patients with confirmed Idiopathic (Immune) Thrombocytopenic Purpura (ITP). This condition results in low platelet counts because of increased destruction of platelets (blood cells important for blood clotting) by the body's immune system. Intravenous immune globulin is given to patients with immune thrombocytopenic purpura (ITP) when it is important to raise the level of platelets circulating in the blood stream. Intravenous immune globulin was first licensed for medical use in the United States in 1981, and immune globulin products in various concentrations and from different preparation/purification methods have been licensed for use in the treatment of ITP since then. In this study, Bayer Corporation is evaluating an intravenous immune globulin preparation that is manufactured in a new way. The product is purer than Bayer's prevous preparations of IGIV and more closely reflects the types of immunoglobulin found in normal blood. The manufacturing process also includes a new viral inactivation step that uses a technique called chromatography. The new product will be referred to a IGIV-C, 10%. Although older formulations of Bayer's intravenous immune globulin have been approved for use by the Federal Drug Administration, the new product to be used in this study is not yet approved. Information learned in this study will become part of an application to license this product (IGIV-C, 10%) in the United States and around the world.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000046-40
Application #
6414326
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1974-10-01
Project End
2002-11-30
Budget Start
Budget End
Support Year
40
Fiscal Year
2000
Total Cost
Indirect Cost
Name
University of North Carolina Chapel Hill
Department
Type
DUNS #
078861598
City
Chapel Hill
State
NC
Country
United States
Zip Code
27599
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