Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
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).
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.
Inclusion Criteria:

 -  Patients indicated per the approved product label for KALBITOR

 -  Patient or guardian is able to understand and sign the informed consent form

 -  Patient is willing and able to undergo a skin test procedure at screening (baseline)

 Exclusion Criteria:

 -  Patient contraindicated per the approved product label for KALBITOR

 -  Patient confirmed pregnancy or active breastfeeding

 -  Any other condition that, in the opinion of the Investigator, may compromise the
 safety or compliance of the patient or would preclude the patient from successful
 completion of the study