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Open-Label, Single-Dose Study to Evaluate the Response and Pharmacokinetics/Pharmacodynamics of Different Doses of CINRYZE [C1 Inhibitor (Human)] For Treatment of Acute Angioedema Attacks in Children Less Than 12 Years of Age With Hereditary Angioedema

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Trial Profile

Open-Label, Single-Dose Study to Evaluate the Response and Pharmacokinetics/Pharmacodynamics of Different Doses of CINRYZE [C1 Inhibitor (Human)] For Treatment of Acute Angioedema Attacks in Children Less Than 12 Years of Age With Hereditary Angioedema

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 06 Nov 2021

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At a glance

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

    • Most Recent Events

    • 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.
    • 15 Sep 2014 New trial record
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