Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
This trial is active, not recruiting.
|Condition||hereditary angioedema (hae)|
|Treatments||cinryze 500, cinryze 1000|
|Start date||February 2014|
|End date||May 2017|
|Trial size||12 participants|
|Trial identifier||NCT02052141, 0624-301, 2013-002453-29, SHP616-301|
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Colorado Springs, CO||Asthma and Allergy Associates, P.C||no longer recruiting|
|Las Vegas, NV||Nevada Access to Research and Education Society||no longer recruiting|
|Eugene, OR||Oregon Allergy Associates||no longer recruiting|
|Frankfurt, Germany||Klinikum der J.W. Goethe Universitat||no longer recruiting|
|Mörfelden-Walldorf, Germany||HZRM Hamophilie Zentrum Rhein Main GmbH||no longer recruiting|
|Tel Aviv, Israel||Tel Aviv Sourasky Medical Center||no longer recruiting|
|Mexico City, Mexico||Instituto Nacional de Pediatria||no longer recruiting|
|Targu-Mures, Romania||Clinical County Hospital Mures||no longer recruiting|
|Manchester, United Kingdom||Royal Manchester Children's Hospital||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
Number of angioedema attacks in each treatment period
time frame: 12 weeks
Number of subjects with adverse events by dose group
time frame: 12 weeks
Change from baseline in C1 inhibitor (C1 INH) and C4 concentrations during each treatment period
time frame: Pre-dose to 1 hour post-dose at Visit 1, Week 6, and Week 12
Number of subjects with C1 INH antibodies
time frame: 28 weeks
Male or female participants from 6 years up to 11 years old.
Inclusion Criteria: - Diagnosis of Type I or Type II HAE. - History of angioedema attacks. Exclusion Criteria: - History of bleeding or clotting abnormality. - 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.
|Official title||A Phase 3, Multicenter, Randomized, Single-Blind, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Intravenous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Prevention of Angioedema Attacks in Children 6 to 11 Years of Age With Hereditary Angioedema|
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