Clinical Trial: A European Post-Authorisation Observational Study Of Patients With Hereditary Angioedema

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A European Multi-Center, Multi-Country, Post-Authorisation, Observational Study (Registry) Of Patients With Hereditary Angioedema (HAE) Who Are Administered CINRYZE®

Brief Summary: This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.

Detailed Summary:
Sponsor: Shire

Current Primary Outcome:

  • Incidence of adverse drug reactions [ Time Frame: 12 months ]
  • Incidence of thrombotic/thromboembolic events [ Time Frame: 12 months ]
  • Occurrence of pregnancy [ Time Frame: 12 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shire

Dates:
Date Received: February 16, 2012
Date Started: March 2012
Date Completion:
Last Updated: October 20, 2016
Last Verified: October 2016