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NCT00167973 Clinical Trial

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

Hemophilia B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00167973
Other study ID # 3090A-101039
Secondary ID
Status Completed
Phase Phase 4
First received September 11, 2005
Last updated May 25, 2010
Start date January 2002
Est. completion date June 2009

Study information
Verified date May 2010
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 218
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with Hemophilia B scheduled to begin treatment with BeneFIX are eligible for Registry enrollment

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Observation for safety Study Duration Yes
See also
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