Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
NCT ID: NCT01059526
Last Updated: 2021-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
81 participants
OBSERVATIONAL
2010-02-01
2014-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients naive to KALBITOR
HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
ecallantide
30 mg SC
Patients non- naive to KALBITOR
HAE patients that have been treated with KALBITOR prior to enrollment in the study
ecallantide
30 mg SC
Interventions
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ecallantide
30 mg SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
16 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
The Bronx, New York, United States
Allergy Partners of Western North Carolina
Asheville, North Carolina, United States
Specialty Medical Clinic And Research Center
Sanford, North Carolina, United States
Department of Internal Medicine, University of Cincinnati -MSB
Cincinnati, Ohio, United States
Optimed Research, LTD
Columbus, Ohio, United States
Reynolds Clinic
Toledo, Ohio, United States
Toledo Institute of Clinical Research
Toledo, Ohio, United States
Allergy Clinic of the Tulsa, Inc.
Tulsa, Oklahoma, United States
Penn State University - Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States
University of Utah, Department of Dermatology
Salt Lake City, Utah, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Virginia Beach, Virginia, United States
Puget Sound Allergy, Asthma and Immunology
Tacoma, Washington, United States
Countries
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Other Identifiers
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DX-88/24
Identifier Type: -
Identifier Source: org_study_id
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