NCT00167973

Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use

A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 218 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.

Conditions

• Hemophilia B

Timeline

• Start date: 2002-01-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2005-09-14
• Last updated: 2010-05-26

Locations

90 sites across 10 countries: Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom