EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of DX-88 (Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema
10 Years
N/A
Both
Hereditary Angioedema
Trial Information
EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of DX-88 (Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema
This is a randomized placebo-controlled trial.
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.
Inclusion Criteria:
- 10 years of age or older
- 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 an investigational drug or device, within 30 days prior to study treatment
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose
Outcome Description:
The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, 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.
Outcome Time Frame:
baseline, 4 hours post-dose
Safety Issue:
No
Principal Investigator
Patrick Horn, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Dyax Corp.
Authority:
United States: Food and Drug Administration
Study ID:
EDEMA4 (DX-88/20)
NCT ID:
NCT00457015
Start Date:
April 2007
Completion Date:
June 2008
Related Keywords:
- Hereditary Angioedema
- Angioedema
- Angioedemas, Hereditary
Name | Location |
|---|---|
| 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 Comprehensive Cancer Center | Berkeley, California 94704 |
| University of Utah | Salt Lake City, Utah |
| Georgetown University Hospital | Washington, District of Columbia 20007 |
| University of Cincinnati | Cincinnati, Ohio 45267-0502 |
| Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
| University of South Florida | Tampa, Florida 33612 |
| Christiana Hospital | Wilmington, Delaware |
| 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 |
| University of Miami, General Clinical Research Center | Miami, Florida 33136 |
| 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 |
| 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 |
| Allergy Partners of Albuquerque | Albuquerque, New Mexico 87109 |
| Allergy Partners of Western North Carolina | Asheville, North Carolina 28801 |
| Optimed Research, LLC | Columbus, Ohio 43235 |
| Asthma Allergy and Pulmonary Associates | Philadelphia, Pennsylvania 19107 |
| Highlands Allergy and Asthma Center, PC | Bristol, Tennessee 37620 |
| AARA Research Center | Dallas, Texas 75231 |
| Clinical Research Associates of Tidewater | Norfolk, Virginia 23507 |
| Puget Sound Allergy, Asthma, & Immunology | Tacoma, Washington 98405 |
| Aaron J. Davis | Scottsdale, Arizona 85251 |
| Asthma and Allergy Institute of Michigan | Clinton TWP, Michigan 48038 |
| UMDNJ-New Jersey Medical School | Newark, New Jersey 07103 |
| Valley Clinical Research Center | Easton, Pennsylvania 18045 |
| Childrens Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15213 |
| The Paull Allergy and Asthma Clinic, P.A. | Bryan, Texas 77802 |
| University of Texas Medical School | Galveston, Texas 77555-1083 |
| Baylor Clinic, Baylor College of Medicine | Houston, Texas 77030 |
