Brief Title
Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use
Official Title
A Prospective Registry of European Hemophilia B Patients Receiving BeneFIX®(Nonacog Alfa, Recombinant Human Factor IX) for Usual Use
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.
Study Type
Observational
Primary Outcome
Observation for safety
Condition
Hemophilia B
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
218
Start Date
January 2002
Completion Date
June 2009
Primary Completion Date
June 2009
Eligibility Criteria
Inclusion Criteria: - Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment Exclusion Criteria:
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00167973
Organization ID
3090A-101039
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
May 2010