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
Tacoma, Washington 98405
1408
mi
from
Tacoma, WA
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
1181
mi
from
Norfolk, VA
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8675 College Boulevard
Overland Park, Kansas 66210
913-345-2383
188
mi
from
Overland Park, KS
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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...
974
mi
from
Pittsburgh, PA
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808
mi
from
Ann Arbor, MI
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Asheville, North Carolina 28801
857
mi
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Asheville, NC
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Bell Gardens, California 90201
1165
mi
from
Bell Gardens, CA
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1291
mi
from
Bronx, NY
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Chestnut Hill, Massachusetts 02467
1438
mi
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Chestnut Hill, MA
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Chevy Chase, Maryland 20815
1124
mi
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Chevy Chase, MD
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610
mi
from
Chicago, IL
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724
mi
from
Cincinnati, OH
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Clinton Township, Michigan 48038
852
mi
from
Clinton Township, MI
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Columbus, Georgia 31904
811
mi
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Columbus, GA
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Columbus, Ohio 43235
809
mi
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Columbus, OH
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Dallas, Texas 75231
342
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Dallas, TX
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Evansville, Indiana 47713
559
mi
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Evansville, IN
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Granada Hills, California 91344
1177
mi
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Granada Hills, CA
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1147
mi
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Hershey, PA
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Iselin, New Jersey 08830
1269
mi
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Iselin, NJ
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694
mi
from
Jefferson, LA
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372
mi
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Little Rock, AR
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1168
mi
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Los Angeles, CA
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Metairie, Louisiana 70006
693
mi
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Metairie, LA
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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,...
1306
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Mineola, NY
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Muncie, Indiana 47304
688
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Muncie, IN
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North Syracuse, New York 13212
1195
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North Syracuse, NY
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Orange, California 92868
1153
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Orange, CA
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1190
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Reno, NV
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Saint Louis, Missouri 63130
411
mi
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Saint Louis, MO
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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...
414
mi
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Saint Louis, MO
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777
mi
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Salt Lake City, UT
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Sanford, North Carolina 27330
1045
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Sanford, NC
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Tampa, Florida 33613
1111
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Tampa, FL
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Toledo, Ohio 43615
804
mi
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Toledo, OH
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804
mi
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Toledo, OH
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Tulsa, Oklahoma 74133
159
mi
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Tulsa, OK
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1196
mi
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Virginia Beach, VA
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Walnut Creek, California 94598
1317
mi
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Walnut Creek, CA
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Waterbury, Connecticut 06708
1338
mi
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Waterbury, CT
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