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Clinical Trial Summary

The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).


Clinical Trial Description

The objective of this study is to evaluate immunogenicity and hypersensitivity upon exposure to KALBITOR, in particular: 1. Determine the rate of anaphylaxis and Type I hypersensitivity reactions upon exposure to KALBITOR. 2. Determine the rate of seroconversion to anti-ecallantide antibodies upon exposure to KALBITOR. 3. Determine the rate of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to KALBITOR. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01059526
Study type Observational
Source Takeda
Contact
Status Completed
Phase
Start date February 1, 2010
Completion date June 1, 2014

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