Immune Thrombocytopenic Purpura Clinical Trial
Official title:
Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults
Octagam is a solvent/detergent-treated human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in about 80 countries. This study evaluated the efficacy and safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura (ITP) in adults. As Octagam 10% is essentially similar to Octagam 5%, it is expected that Octagam 10% is as efficacious and safe (in respect to viral safety) as Octagam 5%.
The primary objective of the study was to investigate the efficacy of Octagam® 10% in
correcting platelet count. The blood count as well as laboratory chemistry were checked
repeatedly up to day 21.
The secondary objective of the study was to investigate the safety of Octagam® 10%. Safety
was assessed by monitoring vital signs, evaluating adverse events, assessing laboratory
parameters, and by viral safety testing.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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