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



Status:Completed
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:16 - Any
Updated:2/22/2018
Start Date:February 1, 2010
End Date:June 1, 2014

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A Phase 4, Long-Term Observational Safety Study to Evaluate Immunogenicity and Hypersensitivity With Exposure to KALBITOR (Ecallantide) for the Treatment of Acute Attacks of HAE

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
We found this trial at
40
sites
Waterbury, Connecticut 06708
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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8675 College Boulevard
Overland Park, Kansas 66210
913-345-2383
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Ann Arbor, MI
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Asheville, North Carolina 28801
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Bell Gardens, California 90201
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Bell Gardens, CA
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Bronx, NY
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Chestnut Hill, Massachusetts 02467
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Chevy Chase, Maryland 20815
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Chicago, IL
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Cincinnati, OH
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Clinton Township, Michigan 48038
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Columbus, Georgia 31904
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Columbus, Ohio 43235
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Dallas, Texas 75231
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Evansville, Indiana 47713
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Granada Hills, California 91344
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Hershey, PA
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Iselin, New Jersey 08830
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Jefferson, LA
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Little Rock, AR
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Metairie, Louisiana 70006
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259 1st St
Mineola, New York 11501
(516) 663-0333
Winthrop University Hospital Founded in 1896 by a group of local physicians and concerned citizens,...
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Muncie, Indiana 47304
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North Syracuse, New York 13212
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Orange, California 92868
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Reno, NV
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Saint Louis, Missouri 63130
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Sanford, North Carolina 27330
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Tacoma, Washington 98405
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Tampa, Florida 33613
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Toledo, Ohio 43615
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Tulsa, Oklahoma 74133
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Virginia Beach, VA
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Walnut Creek, California 94598
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