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

Completed

Conditions studied: Hereditary Angioedema (HAE)

In brief

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).

Key facts

Study ID

NCT01059526

Run by

Shire

People needed

81

Starts

2010-02-01

Expected to finish

2014-06-01

Last updated by the study team

2021-06-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Little Rock Allergry and Asthma Clinical Research Center — Little Rock, Arkansas, United States
• Sunrise Clinical Research — Bell Gardens, California, United States
• Allergy & Asthma Institute of the Valley — Granada Hills, California, United States
• Unidversity of California, Los Angeles David Geffen School of Medicine — Los Angeles, California, United States
• 705 West LaVeta — Orange, California, United States
• Allergy & Asthma Clinical Research Inc. — Walnut Creek, California, United States
• Center for Allergy, Asthma & Immunology — Waterbury, Connecticut, United States
• University of South Florida Asthma — Tampa, Florida, United States
• Brookstone Clinical Research Center — Columbus, Georgia, United States
• University Consultants in Allergry and Immunology — Chicago, Illinois, United States
• Deaconess Clinic Downtown — Evansville, Indiana, United States
• Muncie Allergy Ctr — Muncie, Indiana, United States
• Kansas City Allergy and Asthma Associates — Overland Park, Kansas, United States
• Ochsner Health System - Allergy, Asthma and Immunology Department — Jefferson, Louisiana, United States
• Clinical Research Specialists — Metairie, Louisiana, United States
• Institute for Asthma and Allergy, P.C. — Chevy Chase, Maryland, United States
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
• University of Michigan Health System Allergy Specialty Clinic — Ann Arbor, Michigan, United States
• Asthma and Allergy Institute of Michigan — Clinton Township, Michigan, United States
• Saint Louis University School of Medicine — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nevada School of Medicine - Department of Pediatrics — Reno, Nevada, United States
• Allergy Treatment Center of New Jersey — Iselin, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• Medical Research Associates of CNY — North Syracuse, New York, United States

Full record on ClinicalTrials.gov

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