CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12
NCT ID: NCT01095510
Last Updated: 2021-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
9 participants
INTERVENTIONAL
2010-06-02
2012-04-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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500 U CINRYZE (10-25 kg body weight)
Single IV dose of 500 U CINRYZE
CINRYZE
1000 U CINRYZE (10-25 kg body weight)
Single IV dose of 1000 U CINRYZE
CINRYZE
1000 U CINRYZE (>25 kg body weight)
Single IV dose of 1000 U CINRYZE
CINRYZE
1500 U CINRYZE (>25 kg body weight)
Single IV dose of 1500 U CINRYZE
CINRYZE
Interventions
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CINRYZE
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Be at least 10 kg of body weight.
2. Have a confirmed diagnosis of HAE.
3. Have an acute HAE attack and be able to initiate treatment within 8 hours after onset of symptoms.
Exclusion Criteria
1. Have any active infectious illness.
2. Have had a prior HAE attack and/or received any C1 INH product within 7 days prior to dosing with study drug.
3. Have received therapy with antifibrinolytics (e.g., tranexamic acid), androgens (e.g., danazol, oxandrolone, stanozolol, or testosterone), ecallantide (Kalbitor®), or icatibant (Firazyr®) within 7 days prior to dosing with study drug.
4. Have a history of allergic reaction to C1 INH products, including CINRYZE (or any of the components of CINRYZE), or other blood products.
5. Have participated in any other investigational drug evaluation within 30 days prior to dosing with study drug, or have previously received treatment with CINRYZE in this study at any time.
2 Years
11 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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Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States
University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States
Allergy & Asthma Research Group
Eugene, Oregon, United States
Baker Allergy, Asthma and Dermatology Research Center, LLC
Lake Oswego, Oregon, United States
AARA Research Center
Dallas, Texas, United States
Allergy and Asthma Research Center, P.A.
San Antonio, Texas, United States
Marycliff Allergy Specialists
Spokane, Washington, United States
Charité Universitätsmedizin Berlin, Dept. of Dermatology and Allergy
Berlin, , Germany
Klinikum rechts der Isar, Technical University Munich, ENT Clinic
Munich, , Germany
Semmelweis University, Allergy and Angioedema Outpatients Clinic, Kútvölgyi Clinical Center
Budapest, , Hungary
Countries
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References
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Lumry W, Soteres D, Gower R, Jacobson KW, Li HH, Chen H, Schranz J. Safety and efficacy of C1 esterase inhibitor for acute attacks in children with hereditary angioedema. Pediatr Allergy Immunol. 2015 Nov;26(7):674-80. doi: 10.1111/pai.12444. Epub 2015 Aug 11.
Other Identifiers
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2011-000369-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0624-203
Identifier Type: -
Identifier Source: org_study_id
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