Status:
COMPLETED
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
Lead Sponsor:
Shire
Conditions:
Hereditary Angioedema (HAE)
Eligibility:
All Genders
10+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 design...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00456508
Start Date
April 1 2007
End Date
September 1 2010
Last Update
June 8 2021
Active Locations (41)
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1
Aaron Davis
Scottsdale, Arizona, United States, 85251
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
3
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States, 72205
4
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704