C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
NCT ID: NCT01005888
Last Updated: 2021-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
26 participants
INTERVENTIONAL
2005-03-14
2007-08-22
Brief Summary
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Detailed Description
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The study design also allowed for administration of open-label C1INH-nf (1,000 U of C1INH-nf administered IV \[repeated after 60 minutes, if necessary\] for treatment of laryngeal angioedema or if deemed necessary by the investigator; 1,000 U of C1INH-nf administered IV \[single dose\] prior to emergency surgical procedures).
A total of 26 subjects were enrolled in the study. One subject received open-label C1INH-nf but withdrew prior to randomization. Another subject was randomized but withdrew prior to receiving study drug. Twenty-four (24) subjects were randomized and treated with blinded study drug. In total, 25 subjects received at least 1 dose of study drug and were analyzed for safety; all 25 subjects were exposed to C1INH-nf and 23 subjects were exposed to placebo.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
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C1INH-nf First, then Placebo
1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
C1 esterase inhibitor [human] (C1INH-nf)
Placebo (saline)
Placebo First, then C1INH-nf
Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
C1 esterase inhibitor [human] (C1INH-nf)
Placebo (saline)
Interventions
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C1 esterase inhibitor [human] (C1INH-nf)
Placebo (saline)
Eligibility Criteria
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Inclusion Criteria
* Normal C1q level
* Relatively frequent angioedema attacks (at least 2 per month on average)
Exclusion Criteria
* 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
6 Years
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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Allergy and Immunology Associates
Scottsdale, Arizona, United States
University of California, San Diego
San Diego, California, United States
Allergy and Asthma Clinical Research, Inc
Walnut Creek, California, United States
Atlanta Allergy and Asthma Clinic
Suwanee, Georgia, United States
Hawaii Pacific Health Research Institute
Honolulu, Hawaii, United States
Welborn Clinic Allergy and Immunology
Evansville, Indiana, United States
Lake Charles Memorial Hospital
Lake Charles, Louisiana, United States
Institute for Asthma and Allergy
Wheaton, Maryland, United States
Libby Clinic
Libby, Montana, United States
Mount Sinai School of Medicine
New York, New York, United States
Nationwide Childrens Hospital Clinical Research
Columbus, Ohio, United States
Allergy Clinic of Tulsa
Tulsa, Oklahoma, United States
Allergy Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States
AARA Research Center
Dallas, Texas, United States
Tyler County Hospital
Woodville, Texas, 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.
Lumry WR, Miller DP, Newcomer S, Fitts D, Dayno J. Quality of life in patients with hereditary angioedema receiving therapy for routine prevention of attacks. Allergy Asthma Proc. 2014 Sep-Oct;35(5):371-6. doi: 10.2500/aap.2014.35.3783.
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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LEVP2005-1/Part B
Identifier Type: -
Identifier Source: org_study_id
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