Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167973
Status:
COMPLETED
Last Update Posted:
2010-05-26
First Post:
2005-09-11
Brief Title:
Prospective Registry of European Hemophilia B Patients Receiving BeneFIX for Usual Use
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Organization:
Wyeth is now a wholly owned subsidiary of Pfizer
Study Overview
Official Title:
A Prospective Registry of European Hemophilia B Patients Receiving BeneFIXNonacog Alfa Recombinant Human Factor IX for Usual Use
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None