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LEVP2005-1/Part B: A Double-blind, Placebo-Controlled, Clinical Study to Investigate the Efficacy and Safety of Purified C1 Esterase Inhibitor (Human) as Prophylactic Treatment to Prevent HAE Attacks

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Trial Profile

LEVP2005-1/Part B: A Double-blind, Placebo-Controlled, Clinical Study to Investigate the Efficacy and Safety of Purified C1 Esterase Inhibitor (Human) as Prophylactic Treatment to Prevent HAE Attacks

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Complement C1 inhibitor protein (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms CHANGE-1
  • Sponsors Shire; ViroPharma

    • Most Recent Events

    • 01 Mar 2021 Results of an analysis evaluating comparative efficacy using data from two clinical studies: HELP and CHANGE published in the Drugs in R and D
    • 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.
    • 06 Mar 2017 Results of a pooled analysis of two phase III studies (CHANGE and COMPACT), presented at the 2017 Annual Meeting of the American Academy of Allergy, Asthma and Immunology

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