Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)

Completed · Phase 3

Conditions studied: Hereditary Angioedema (HAE)

In brief

The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Key facts

Study ID

NCT00456508

Run by

Shire

People needed

147

Starts

2007-04-01

Expected to finish

2010-09-01

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
• Documented diagnosis of HAE (Type I or II)
• Willing and able to give informed consent
• Acute HAE attack at time of presentation

You may not qualify if…

• Receipt of an investigational drug or device, within 30 days prior to study treatment, other than DX-88 (ecallantide)
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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