Open-label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks
This is an open label trial.
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing
Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.
4 hrs post dose after every episode
No
Bill Pullman, MD, PhD
Study Director
Dyax Corp.
United States: Food and Drug Administration
DX-88/19
NCT00456508
April 2007
September 2010
Name | Location |
---|---|
University of Utah Health Sciences Center | Salt Lake City, Utah 84132 |
Children's Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
Winthrop University Hospital | Mineola, New York 11501 |
Arkansas Children's Hospital | Little Rock, Arkansas 72202-3591 |
Brigham and Women's Hospital | Boston, Massachusetts 02115 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Penn State Milton S Hershey Medical Center | Hershey, Pennsylvania 17033 |
Aaron Davis | Scottsdale, Arizona 85251 |
Little Rock Allergy & Asthma Clinic | Little Rock, Arkansas 72205 |
Pacific Coast Allergy | Crescent City, California 95531 |
Jacob Offenberger | Granada Hills, California 91344 |
UCLA David Geffen School of Medicine, Department of Medicine | Los Angeles, California 90095-1680 |
Asthma and Allergy Associates, P.C. | Colorado Springs, Colorado 80907 |
Christiana Hospital, Christiana Care Health Services | Newark, Delaware 19718 |
Georgetown University Medical Center, Georgetown University Hospital | Washington, District of Columbia 20007 |
University of Miami, General Clinical Research Center | Miami, Florida 33136 |
University of South Florida, Asthma, Allergy and Immunology Clinical Research Unit | Tampa, Florida 33613 |
Roberson Allergy and Asthma | West Palm Beach, Florida 33401 |
Family Allergy & Asthma Center, PC | Atlanta, Georgia 30342 |
Allergy Center of Brookstone | Columbus, Georgia 31904 |
University Consultants in Allergy and Immunology | Chicago, Illinois 60612 |
Muncie Allergy Center | Muncie, Indiana 47304 |
Kansas City Allergy & Asthma | Overland Park, Kansas 66210 |
Institute for Asthma and Allergy | Wheaton, Maryland 20902 |
Asthma and Allergy Institutes of Michigan | Clinton TWP, Michigan 48038 |
Respiratory Medicine Research Institute of Michigan, PLC | Ypsilanti, Michigan 48197 |
Nevada Access to Research and Education Society | Las Vegas, Nevada 89102 |
University of Nevada School of Medicine | Reno, Nevada 89503 |
UMDNJ- New Jersey Medical School | Newark, New Jersey 07103 |
Allergy Partners of Albuquerque | Albuquerque, New Mexico 87109 |
Allergy Partners of Western North Carolina | Asheville, North Carolina 28801 |
University of Cincinnati, Division of Internal Medicine | Cincinnati, Ohio 45267 |
Optimed Research, LLC | Columbus, Ohio 43235 |
Asthma Allergy and Pulmonary Associates | Philadelphia, Pennsylvania 19107 |
Highlands Allergy and Asthma Center, PC | Bristol, Tennessee 37620 |
The Paull Allergy and Asthma Clinic, P.A | Bryan, Texas 77802 |
AARA Research Center | Dallas, Texas 75231 |
Clinical Research Associates of Tidewater | Norfolk, Virginia 23507 |
Puget Sound Allergy, Asthma, & Immunology | Tacoma, Washington 98405 |