Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Shire
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.
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
