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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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Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2023

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At a glance

Most Recent Events

  • 25 Feb 2019 Safety and efficacy data from two phase 3 studies (NCT01005888 and NCT02052141) and an open-label trial (NCT00462709) were presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.
  • 21 Jun 2018 According to a Shire media release, CINRYZE has been approved in the U.S. since October 2008 for routine prophylaxis against attacks in adolescents and adults living with HAE.The approval was based on data from this trial.
  • 05 Mar 2018 Results presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology

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