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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Ecallantide

Criteria

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