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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00167973

Enrollment

218

Registered

2005-09-14

Start date

2002-01-31

Completion date

2009-06-30

Last updated

2010-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia B

Keywords

Hemophilia B

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Observation for safety	Study Duration

Countries

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

Outcome results