Status:
COMPLETED
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Lead Sponsor:
Shire
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
Eligibility Criteria
Inclusion
- \- History of at least 1 HAE attack per month or any history of laryngeal edema
- In addition, this study was open to all subjects who:
- Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B
- Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed
- Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up
- Were excluded from LEVP2005-1 for any of the following reasons:
- Pregnancy or lactation
- Age less than 6 years
- Narcotic addiction
- Presence of anti-C1 inhibitor (C1INH) autoantibodies
- Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:
- Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
- Had a known HAE-causing C1INH mutation, or
- Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator
Exclusion
- History of allergic reaction to C1INH or other blood products
- Participated in any other investigational drug study within the past 30 days other than those sponsored by Lev Pharmaceuticals
- Received blood or a blood product in the past 60 days other than C1INH-nf
Key Trial Info
Start Date :
June 27 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2009
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00462709
Start Date
June 27 2006
End Date
March 31 2009
Last Update
June 8 2021
Active Locations (48)
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1
Clinical Research Consultants, Inc
Hoover, Alabama, United States, 35216
2
Allergy and Immunology Associates
Scottsdale, Arizona, United States, 85251
3
Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States, 72712
4
UCLA-David Geffen School of Medicine
Los Angeles, California, United States, 90095