Status:
COMPLETED
Efficacy Study of DX-88 (Ecallantide) 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 evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.
Detailed Description
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 at...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00457015
Start Date
April 1 2007
End Date
June 1 2008
Last Update
June 8 2021
Active Locations (45)
Enter a location and click search to find clinical trials sorted by distance.
1
Aaron J. 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 Comprehensive Cancer Center
Berkeley, California, United States, 94704