Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
NCT ID: NCT02052141
Last Updated: 2021-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
12 participants
INTERVENTIONAL
2014-03-20
2017-05-04
Brief Summary
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Secondary Objectives - To assess the safety and tolerability, characterize the pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
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500/1000
500 Units of CINRYZE administered by IV injection twice per week for 12 weeks followed by 1000 Units of CINRYZE administered by IV injection twice per week for 12 weeks
CINRYZE 500
500 Units of CINRYZE administered by IV injection
CINRYZE 1000
1000 Units of CINRYZE administered by IV injection
1000/500
1000 Units of CINRYZE administered by IV injection twice per week for 12 weeks followed by 500 Units of CINRYZE administered by IV injection twice per week for 12 weeks
CINRYZE 500
500 Units of CINRYZE administered by IV injection
CINRYZE 1000
1000 Units of CINRYZE administered by IV injection
Interventions
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CINRYZE 500
500 Units of CINRYZE administered by IV injection
CINRYZE 1000
1000 Units of CINRYZE administered by IV injection
Eligibility Criteria
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Inclusion Criteria
* History of angioedema attacks.
Exclusion Criteria
* Diagnosis of acquired angioedema or known to have C1 INH antibodies.
* History of allergic reaction to C1 esterase inhibitor or other blood products.
* Receipt of any experimental agents other than those required for prevention or treatment of angioedema attacks within 30 days prior to screening.
6 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 and Allergy Associates, P.C
Colorado Springs, Colorado, United States
Nevada Access to Research and Education Society
Las Vegas, Nevada, United States
Oregon Allergy Associates
Eugene, Oregon, United States
Klinikum der J.W. Goethe Universitat
Frankfurt, , Germany
HZRM Hamophilie Zentrum Rhein Main GmbH
Mörfelden-Walldorf, , Germany
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Instituto Nacional de Pediatria
Mexico City, , Mexico
Clinical County Hospital Mures
Târgu Mureş, , Romania
Countries
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References
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Aygoren-Pursun E, Soteres D, Moldovan D, Christensen J, Van Leerberghe A, Hao J, Schranz J, Jacobson KW, Martinez-Saguer I. Preventing Hereditary Angioedema Attacks in Children Using Cinryze(R): Interim Efficacy and Safety Phase 3 Findings. Int Arch Allergy Immunol. 2017;173(2):114-119. doi: 10.1159/000477541. Epub 2017 Jun 30.
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.
Aygoren-Pursun E, Soteres DF, Nieto-Martinez SA, Christensen J, Jacobson KW, Moldovan D, Van Leerberghe A, Tang Y, Lu P, Vardi M, Schranz J, Martinez-Saguer I. A randomized trial of human C1 inhibitor prophylaxis in children with hereditary angioedema. Pediatr Allergy Immunol. 2019 Aug;30(5):553-561. doi: 10.1111/pai.13060. Epub 2019 May 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2013-002453-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP616-301
Identifier Type: OTHER
Identifier Source: secondary_id
0624-301
Identifier Type: -
Identifier Source: org_study_id
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