Clinical Trial: Firazyr® Patient Registry Protocol (Icatibant Outcome Survey - IOS)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Firazyr® Patient Registry Protocol (Icatibant Outcome Survey - IOS)
Brief Summary: The Firazyr® Patient Registry is a prospective, observational study designed to document the routine clinical outcomes over time in patients treated with Firazyr® in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr® in routine clinical practice and as a data source for post-marketing investigations.
Detailed Summary: The Firazyr® Patient Registry is a multicenter, prospective, observational study for patients treated with Firazyr® in countries where it is currently approved. The entry of patients into the Firazyr® Registry is at the discretion of the physician and the patient and is not a pre-requisite for prescribing Firazyr®.
Sponsor: Shire
Current Primary Outcome: To monitor the safety of Firazyr® during long-term treatment [ Time Frame: Non-interventional patient registry ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Shire
Dates:
Date Received: December 17, 2009
Date Started: May 2009
Date Completion: August 2019
Last Updated: January 26, 2017
Last Verified: January 2017