Status:
COMPLETED
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment 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 repeat use of C1INH-nf for the treatment of acute HAE attacks.
Detailed Description
A total of 113 subjects were enrolled in the study. One-hundred-one (101) subjects received C1INH-nf for the treatment of 1 or more HAE attacks and were analyzed for efficacy. The study design also al...
Eligibility Criteria
Inclusion
- This study was open to all subjects who:
- Completed participation in LEVP2005-1/A (NCT00289211) and were not participating in LEVP2005-1/B (NCT01005888), any time after the 3-day telephone follow-up
- Completed participation in LEVP2005-1/B any time after the final prophylactic therapy in Part B
- Were enrolled but not randomized in LEVP2005-1/A after Part A was closed
- Were excluded from LEVP2005-1 for any of the following reasons:
- Pregnancy or lactation
- Age less than 6 years
- Narcotic addiction
- Presence of anti-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
- Received blood or a blood product in the past 60 days other than C1INH-nf
Key Trial Info
Start Date :
September 21 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2009
Estimated Enrollment :
113 Patients enrolled
Trial Details
Trial ID
NCT00438815
Start Date
September 21 2006
End Date
March 31 2009
Last Update
June 8 2021
Active Locations (30)
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1
Allergy and Immunology Associates
Scottsdale, Arizona, United States, 85251
2
Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States, 72712
3
UCLA-David Geffen School of Medicine
Los Angeles, California, United States, 90095
4
University of California, San Diego
San Diego, California, United States, 92093-0732