Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
NCT ID: NCT00462709
Last Updated: 2021-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
146 participants
INTERVENTIONAL
2006-06-27
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Open-label C1INH-nf
1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.
C1 esterase inhibitor [human] (C1INH-nf)
Interventions
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C1 esterase inhibitor [human] (C1INH-nf)
Eligibility Criteria
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Inclusion Criteria
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 Criteria
* 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
1 Year
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Clinical Research Consultants, Inc
Hoover, Alabama, United States
Allergy and Immunology Associates
Scottsdale, Arizona, United States
Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States
UCLA-David Geffen School of Medicine
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
Allergy and Asthma Associates of Santa Clara
San Jose, California, 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 Center of East Orlando
Orlando, Florida, United States
Cleveland Clinic
Weston, Florida, United States
Family Allergy and Asthma Center
Atlanta, Georgia, United States
Atlanta Allergy and Asthma Clinic
Suwanee, Georgia, United States
University Consultants in Allergy & Immunology
Chicago, Illinois, United States
Welborn Clinic
Evansville, Indiana, United States
Private Practice
Liberal, Kansas, United States
Olathe Medical Center
Olathe, Kansas, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Family Asthma and Allergy Research Center
Louisville, Kentucky, United States
Asthma Allergy and Sinus Center
Waldorf, Maryland, United States
Institute for Asthma and Allergy
Wheaton, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Grand Traverse Allergy
Traverse City, Michigan, United States
MeritCare Clinical Research
Bemidji, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
St. Louis University School of Medicine
St 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
Private Practice
Hastings-on-Hudson, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Allergy Partners of East Carolina
Greenville, North Carolina, United States
Legacy Pharma Research
Bismarck, North Dakota, United States
MeritCare Clinical Research
Fargo, North Dakota, United States
Nationwide Childrens Hospital Clinical Research
Columbus, Ohio, United States
Allergy Clinic of Tulsa
Tulsa, Oklahoma, United States
Oregon Medical Group
Eugene, Oregon, United States
Allergy Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States
Penn State University
Hershey, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - Pediatric Pulmonary/Allergy and Immunology
Houston, Texas, United States
Allergy and Asthma Research Center
San Antonio, Texas, United States
Tyler County Hospital
Woodville, Texas, United States
Virginia Adult and Pediatric Allergy and Asthma
Richmond, Virginia, United States
Marycliff Allergy Specialists
Spokane, Washington, United States
Puget Sound Allergy, Asthma and Immunology
Tacoma, Washington, United States
St. Joseph's Hospital/Cornerstone Healthcare
Parkersburg, West Virginia, United States
Countries
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References
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Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
Baker JW, Craig TJ, Riedl MA, Banerji A, Fitts D, Kalfus IN, Uknis ME. Nanofiltered C1 esterase inhibitor (human) for hereditary angioedema attacks in pregnant women. Allergy Asthma Proc. 2013 Mar-Apr;34(2):162-9. doi: 10.2500/aap.2013.34.3645.
Lumry W, Manning ME, Hurewitz DS, Davis-Lorton M, Fitts D, Kalfus IN, Uknis ME. Nanofiltered C1-esterase inhibitor for the acute management and prevention of hereditary angioedema attacks due to C1-inhibitor deficiency in children. J Pediatr. 2013 May;162(5):1017-22.e1-2. doi: 10.1016/j.jpeds.2012.11.030. Epub 2013 Jan 11.
Zuraw BL, Busse PJ, White M, Jacobs J, Lumry W, Baker J, Craig T, Grant JA, Hurewitz D, Bielory L, Cartwright WE, Koleilat M, Ryan W, Schaefer O, Manning M, Patel P, Bernstein JA, Friedman RA, Wilkinson R, Tanner D, Kohler G, Gunther G, Levy R, McClellan J, Redhead J, Guss D, Heyman E, Blumenstein BA, Kalfus I, Frank MM. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):513-22. doi: 10.1056/NEJMoa0805538.
Other Identifiers
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LEVP2006-4
Identifier Type: -
Identifier Source: org_study_id
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