Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
NCT ID: NCT00456508
Last Updated: 2021-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
147 participants
INTERVENTIONAL
2007-04-01
2010-09-01
Brief Summary
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Detailed Description
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The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DX-88 (ecallantide)
DX-88 (ecallantide) Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
ecallantide
solution for SC injection, one 30 mg dose per HAE attack
Interventions
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ecallantide
solution for SC injection, one 30 mg dose per HAE attack
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of HAE (Type I or II)
* Willing and able to give informed consent
* Acute HAE attack at time of presentation
Exclusion Criteria
* Pregnancy or breastfeeding
* Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment
* Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is offered
10 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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Aaron Davis
Scottsdale, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States
Pacific Coast Allergy
Crescent City, California, United States
Jacob Offenberger
Granada Hills, California, United States
UCLA David Geffen School of Medicine, Department of Medicine
Los Angeles, California, United States
Asthma and Allergy Associates, P.C.
Colorado Springs, Colorado, United States
Christiana Hospital, Christiana Care Health Services
Newark, Delaware, United States
Georgetown University Medical Center, Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Miami, General Clinical Research Center
Miami, Florida, United States
University of South Florida, Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States
Roberson Allergy and Asthma
West Palm Beach, Florida, United States
Family Allergy & Asthma Center, PC
Atlanta, Georgia, United States
Allergy Center of Brookstone
Columbus, Georgia, United States
University Consultants in Allergy and Immunology
Chicago, Illinois, United States
Muncie Allergy Center
Muncie, Indiana, United States
Kansas City Allergy & Asthma
Overland Park, Kansas, United States
Institute for Asthma and Allergy
Wheaton, Maryland, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
Asthma and Allergy Institutes of Michigan
Clinton Township, Michigan, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States
Nevada Access to Research and Education Society
Las Vegas, Nevada, United States
University of Nevada School of Medicine
Reno, Nevada, United States
UMDNJ- New Jersey Medical School
Newark, New Jersey, United States
Allergy Partners of Albuquerque
Albuquerque, New Mexico, United States
Winthrop University Hospital
Mineola, New York, United States
Allergy Partners of Western North Carolina
Asheville, North Carolina, United States
University of Cincinnati, Division of Internal Medicine
Cincinnati, Ohio, United States
Optimed Research, LLC
Columbus, Ohio, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Asthma Allergy and Pulmonary Associates
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Highlands Allergy and Asthma Center, PC
Bristol, Tennessee, United States
The Paull Allergy and Asthma Clinic, P.A
Bryan, Texas, United States
AARA Research Center
Dallas, Texas, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States
Puget Sound Allergy, Asthma, & Immunology
Tacoma, Washington, United States
Allergy and Asthma Research Centre
Ottawa, Ontario, Canada
Jordan University Hospital
Amman, , Jordan
Countries
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References
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Rubinstein E, Stolz LE, Sheffer AL, Stevens C, Bousvaros A. Abdominal attacks and treatment in hereditary angioedema with C1-inhibitor deficiency. BMC Gastroenterol. 2014 Apr 9;14:71. doi: 10.1186/1471-230X-14-71.
MacGinnitie AJ, Davis-Lorton M, Stolz LE, Tachdjian R. Use of ecallantide in pediatric hereditary angioedema. Pediatrics. 2013 Aug;132(2):e490-7. doi: 10.1542/peds.2013-0646. Epub 2013 Jul 22.
Sheffer AL, MacGinnitie AJ, Campion M, Stolz LE, Pullman WE. Outcomes after ecallantide treatment of laryngeal hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2013 Mar;110(3):184-188.e2. doi: 10.1016/j.anai.2012.12.007. Epub 2013 Jan 5.
Li HH, Campion M, Craig TJ, Soteres DF, Riedl M, Lumry WR, MacGinnitie AJ, Shea EP, Bernstein JA. Analysis of hereditary angioedema attacks requiring a second dose of ecallantide. Ann Allergy Asthma Immunol. 2013 Mar;110(3):168-72. doi: 10.1016/j.anai.2012.12.004. Epub 2013 Jan 8.
Other Identifiers
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DX-88/19
Identifier Type: -
Identifier Source: org_study_id
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