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

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

Official Title: A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor

Brief 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.

Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Current Primary Outcome: Observation for safety [ Time Frame: Study Duration ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wyeth is now a wholly owned subsidiary of Pfizer

Dates:
Date Received: September 11, 2005
Date Started: January 2002
Date Completion:
Last Updated: May 25, 2010
Last Verified: May 2010