Status:
COMPLETED
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
Lead Sponsor:
Shire
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
6+ years
Phase:
PHASE3
Brief Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.
Detailed Description
Randomized subjects treated for a qualifying attack were eligible to receive rescue dosing with 1,000 U of C1INH-nf if they did not achieve beginning of substantial relief of the defining symptom with...
Eligibility Criteria
Inclusion
- Documented HAE
- Normal C1q level
Exclusion
- Low C1q level
- B-cell malignancy
- Presence of anti-C1INH autoantibody
- History of allergic reaction to C1INH or other blood products
- Narcotic addiction
- Current participation in any other investigational drug study or within the past 30 days
- Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
- Pregnancy or lactation
- Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
Key Trial Info
Start Date :
March 14 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 13 2007
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00289211
Start Date
March 14 2005
End Date
April 13 2007
Last Update
June 11 2021
Active Locations (37)
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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
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