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

Shire

Status

Completed

Conditions

Hereditary Angioedema (HAE)

Treatments

Drug: ecallantide

Study type

Observational

Funder types

Industry

Identifiers

NCT01059526

DX-88/24

Details and patient eligibility

About

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).

Full description

The objective of this study is to evaluate immunogenicity and hypersensitivity upon exposure to KALBITOR, in particular:

Determine the rate of anaphylaxis and Type I hypersensitivity reactions upon exposure to KALBITOR.
Determine the rate of seroconversion to anti-ecallantide antibodies upon exposure to KALBITOR.
Determine the rate of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to KALBITOR.

Enrollment

81 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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