Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)
NCT ID: NCT00457015
Last Updated: 2021-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
96 participants
INTERVENTIONAL
2007-04-01
2008-06-01
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 versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. This study is conducted under Special Protocol Assessment with the FDA and is designed to provide pivotal efficacy data on 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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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DX-88 (ecallantide)
DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections.
ecallantide
dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
Placebo
Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
Phosphate Buffer Saline (PBS), pH 7.0
given as three 1mL subcutaneous injections.
Interventions
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ecallantide
dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
Phosphate Buffer Saline (PBS), pH 7.0
given as three 1mL subcutaneous injections.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Executed informed consent
* Documented diagnosis of HAE (Type I or II)
* Presentation at the site within 8 hours of patient recognition of an moderate to severe HAE acute attack
Exclusion Criteria
* Receipt of non-investigational C1-INH within 7 days of treatment
* Receipt of DX-88 (ecallantide) within 3 days prior to study treatment
* Diagnosis of acquired angioedema (AAE), estrogen-dependent angioedema or drug-induced angioedema (including angiotensin-converting enzyme inhibitor induced angioedema)
* Pregnancy or breastfeeding
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 J. 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 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
Newark, Delaware, United States
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
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 Institute 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
Cincinnati, Ohio, United States
Optimed Research, LLC
Columbus, Ohio, United States
Valley Clinical Research Center
Easton, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Asthma Allergy and Pulmonary Associates
Philadelphia, Pennsylvania, United States
Childrens 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 Texas Medical School
Galveston, Texas, United States
Baylor Clinic, Baylor College of Medicine
Houston, Texas, United States
University of Utah
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 Center
Ottawa, Ontario, Canada
University of Toronto
Toronto, 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.
Bernstein JA, Shea EP, Koester J, Iarrobino R, Pullman WE. Assessment of rebound and relapse following ecallantide treatment for acute attacks of hereditary angioedema. Allergy. 2012 Sep;67(9):1173-80. doi: 10.1111/j.1398-9995.2012.02864.x. Epub 2012 Jul 5.
Riedl M, Campion M, Horn PT, Pullman WE. Response time for ecallantide treatment of acute hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2010 Dec;105(6):430-436.e2. doi: 10.1016/j.anai.2010.09.005. Epub 2010 Oct 25.
Other Identifiers
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EDEMA4 (DX-88/20)
Identifier Type: -
Identifier Source: org_study_id
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