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

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

Completed
Phase of Trial: Phase II

Latest Information Update: 15 Feb 2018

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.
    • 10 Jun 2017 Biomarkers information updated
    • 15 Sep 2014 New trial record
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top