Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

LEVP2006-1 CHANGE 2 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Safety/Efficacy Repeat Exposure Study of C1INH-nf (Human) in the Treatment of Acute HAE Attacks

Next Previous
Trial Profile

LEVP2006-1 CHANGE 2 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Safety/Efficacy Repeat Exposure Study of C1INH-nf (Human) in the Treatment of Acute HAE Attacks

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Complement C1 inhibitor protein (Primary)
  • Indications Hereditary angioedema
  • Focus Registrational; Therapeutic Use
  • Acronyms CHANGE-2
  • Sponsors 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.
  • 02 Apr 2014 New trial record

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top