NCT01034969

Firazyr® Patient Registry (Icatibant Outcome Survey - IOS)

Icatibant Outcome Survey (IOS) Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,761 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The Icatibant Outcome Survey (IOS) is a prospective, observational disease registry designed to document the routine clinical outcomes over time in participants with angioedema treated with Firazyr® (icatibant) and/or Cinryze® (C1 inhibitor \[human\]) in countries where it is currently approved. The data collected will be used to evaluate the safety of Firazyr (icatibant) and Cinryze (C1 inhibitor \[human\]) in routine clinical practice and as a data source for post-marketing investigations.

Detailed description

The Icatibant Outcome Survey (IOS) is a multicenter, prospective, observational study for participants treated with Firazyr (icatibant) and/or Cinryze (C1 inhibitor \[human\]) in countries where it is currently approved. The entry of participants in the Icatibant Outcome Survey (IOS) is at the discretion of the physician and the participant and is not a pre-requisite for prescribing Firazyr (icatibant) or Cinryze (C1 inhibitor \[human\]).

Conditions

• Hereditary Angioedema (HAE)

Timeline

• Start date: 2009-07-10
• Primary completion: 2024-05-31
• Completion: 2024-05-31
• First posted: 2009-12-18
• Last updated: 2024-10-28

Locations

74 sites across 14 countries: Australia, Austria, Brazil, Czechia, Denmark, France, Germany, Greece, Ireland, Israel, Italy, Spain, Sweden, United Kingdom