Status:
COMPLETED
Efficacy and Safety Study of DX-88 to Treat Acute 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 determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe a...
Eligibility Criteria
Inclusion
- Age 10 and older
- Documented diagnosis of HAE, Type I or II
- Executed informed consent
- Presentation for treatment within 8 hours of patient recognition of moderate to severe HAE attack
Exclusion
- Receipt of investigational drug or device, other than DX-88, within 30 days of treatment
- Receipt of non-investigational C1-INH (C1 esterase inhibitor) within 7 days of treatment
- Diagnostic of acquired angioedema, estrogen-dependent angioedema or drug induced angioedema
- Pregnancy or breastfeeding
- Patients who have received DX-88 within 7 days of presentation for dosing in the Double-blind Phase
Key Trial Info
Start Date :
December 31 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2007
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00262080
Start Date
December 31 2005
End Date
February 28 2007
Last Update
June 11 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute for Asthma and Allergy
Wheaton, Maryland, United States, 20902