Clinical Trial: Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 t
Brief Summary:
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.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome: Number of angioedema attacks in each treatment period [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Shire
Dates:
Date Received: January 30, 2014
Date Started: February 2014
Date Completion:
Last Updated: May 24, 2017
Last Verified: May 2017
