Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)

Completed · Phase 3 · Has a placebo group

Conditions studied: Hereditary Angioedema (HAE)

In brief

The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.

Key facts

Study ID

NCT00457015

Run by

Shire

People needed

96

Starts

2007-04-01

Expected to finish

2008-06-01

Last updated by the study team

2021-06-08

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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