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
Clinton Township, Michigan 48038
182
mi
from 43215
Clinton Township, MI
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
422
mi
from 43215
Norfolk, VA
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8675 College Boulevard
Overland Park, Kansas 66210
913-345-2383
625
mi
from 43215
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...
165
mi
from 43215
Pittsburgh, PA
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167
mi
from 43215
Ann Arbor, MI
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Asheville, North Carolina 28801
302
mi
from 43215
Asheville, NC
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Bell Gardens, California 90201
1969
mi
from 43215
Bell Gardens, CA
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482
mi
from 43215
Bronx, NY
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Chestnut Hill, Massachusetts 02467
637
mi
from 43215
Chestnut Hill, MA
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Chevy Chase, Maryland 20815
324
mi
from 43215
Chevy Chase, MD
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274
mi
from 43215
Chicago, IL
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97
mi
from 43215
Cincinnati, OH
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Columbus, Georgia 31904
529
mi
from 43215
Columbus, GA
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Columbus, Ohio 43235
9
mi
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Columbus, OH
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Evansville, Indiana 47713
280
mi
from 43215
Evansville, IN
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Granada Hills, California 91344
1979
mi
from 43215
Granada Hills, CA
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337
mi
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Hershey, PA
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Iselin, New Jersey 08830
460
mi
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Iselin, NJ
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800
mi
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Jefferson, LA
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622
mi
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Little Rock, AR
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1972
mi
from 43215
Los Angeles, CA
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Metairie, Louisiana 70006
797
mi
from 43215
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,...
496
mi
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Mineola, NY
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Muncie, Indiana 47304
125
mi
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Muncie, IN
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North Syracuse, New York 13212
418
mi
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North Syracuse, NY
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Orange, California 92868
1959
mi
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Orange, CA
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1940
mi
from 43215
Reno, NV
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Saint Louis, Missouri 63130
400
mi
from 43215
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...
397
mi
from 43215
Saint Louis, MO
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1511
mi
from 43215
Salt Lake City, UT
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Sanford, North Carolina 27330
375
mi
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Sanford, NC
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Tacoma, Washington 98405
2013
mi
from 43215
Tacoma, WA
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Tampa, Florida 33613
821
mi
from 43215
Tampa, FL
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Toledo, Ohio 43615
119
mi
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Toledo, OH
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119
mi
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Toledo, OH
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Tulsa, Oklahoma 74133
749
mi
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Tulsa, OK
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437
mi
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Virginia Beach, VA
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Walnut Creek, California 94598
2083
mi
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Walnut Creek, CA
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Waterbury, Connecticut 06708
533
mi
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Waterbury, CT
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