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LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks

Trial Profile

LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Feb 2019

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At a glance

  • Drugs Complement C1 inhibitor protein (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms CHANGE-3
  • Sponsors Shire; ViroPharma
  • 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.
    • 31 Aug 2018 Biomarkers information updated
    • 15 Feb 2018 According to a Shire media release, based on the data of LEVP 2006-1, LEVP 2006-4, 0624-203 and 0624-301 studies, U.S. FDA has accepted the CINRYZE (C1 esterase inhibitor [human]) sBLA to expand the currently approved indication to include children aged 6 years and older with hereditary angioedema (HAE). The FDA is expected to provide a decision on the expanded indication of CINRYZE by June 20, 2018, based on the Prescription Drug User Fee Act V action date.
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