Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
- Conditions
- Hereditary Angioedema
- Interventions
- Biological: C1 esterase inhibitor [human] (C1INH-nf)
- Registration Number
- NCT00462709
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 146
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open-label C1INH-nf C1 esterase inhibitor [human] (C1INH-nf) 1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.
- Primary Outcome Measures
Name Time Method Frequency of All HAE Attacks Duration of the study A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (46)
UCLA-David Geffen School of Medicine
🇺🇸Los Angeles, California, United States
University Consultants in Allergy & Immunology
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Family Allergy and Asthma Center
🇺🇸Atlanta, Georgia, United States
Grand Traverse Allergy
🇺🇸Traverse City, Michigan, United States
Nationwide Childrens Hospital Clinical Research
🇺🇸Columbus, Ohio, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
Allergy and Immunology Associates
🇺🇸Scottsdale, Arizona, United States
Allergy and Asthma Center of East Orlando
🇺🇸Orlando, Florida, United States
Allergy and Asthma Clinic of Northwest Arkansas
🇺🇸Bentonville, Arkansas, United States
Cleveland Clinic
🇺🇸Weston, Florida, United States
University of California, San Diego
🇺🇸San Diego, California, United States
Allergy and Asthma Research Center
🇺🇸San Antonio, Texas, United States
MeritCare Clinical Research
🇺🇸Fargo, North Dakota, United States
Legacy Pharma Research
🇺🇸Bismarck, North Dakota, United States
Olathe Medical Center
🇺🇸Olathe, Kansas, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Clinical Research Consultants, Inc
🇺🇸Hoover, Alabama, United States
Allergy and Asthma Clinical Research, Inc
🇺🇸Walnut Creek, California, United States
Allergy and Asthma Center
🇺🇸Fort Lauderdale, Florida, United States
Allergy and Asthma Associates of Santa Clara
🇺🇸San Jose, California, United States
Welborn Clinic
🇺🇸Evansville, Indiana, United States
Atlanta Allergy and Asthma Clinic
🇺🇸Suwanee, Georgia, United States
Asthma Allergy and Sinus Center
🇺🇸Waldorf, Maryland, United States
Institute for Asthma and Allergy
🇺🇸Wheaton, Maryland, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
Family Asthma and Allergy Research Center
🇺🇸Louisville, Kentucky, United States
Private Practice
🇺🇸Hastings-on-Hudson, New York, United States
St. Louis University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Nevada Access to Research and Education Society
🇺🇸Las Vegas, Nevada, United States
UMDNJ Asthma and Allergy Research Center
🇺🇸Newark, New Jersey, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Allergy Partners of East Carolina
🇺🇸Greenville, North Carolina, United States
Winthrop University Hospital
🇺🇸Mineola, New York, United States
Allergy Clinic of Tulsa
🇺🇸Tulsa, Oklahoma, United States
Penn State University
🇺🇸Hershey, Pennsylvania, United States
Oregon Medical Group
🇺🇸Eugene, Oregon, United States
Allergy Asthma and Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
University of Texas - Pediatric Pulmonary/Allergy and Immunology
🇺🇸Houston, Texas, United States
Virginia Adult and Pediatric Allergy and Asthma
🇺🇸Richmond, Virginia, United States
Tyler County Hospital
🇺🇸Woodville, Texas, United States
Puget Sound Allergy, Asthma and Immunology
🇺🇸Tacoma, Washington, United States
St. Joseph's Hospital/Cornerstone Healthcare
🇺🇸Parkersburg, West Virginia, United States
Marycliff Allergy Specialists
🇺🇸Spokane, Washington, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States