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