Status:
COMPLETED
Post Marketing Observational Study of Reformulated BeneFIX
Lead Sponsor:
Pfizer
Conditions:
Hemophilia B
Eligibility:
All Genders
Brief Summary
The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to col...
Detailed Description
No sampling
Eligibility Criteria
Inclusion
- Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.
- Subjects who have dated and signed the informed consent form.
Exclusion
- Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.
- Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00835068
Start Date
January 1 2009
End Date
October 1 2013
Last Update
September 17 2014
Active Locations (17)
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1
Pfizer Investigational Site
Chamberry, Cedex, France, 73011
2
Pfizer Investigational Site
Le Chesnay, Cedex, France, 78157
3
Pfizer Investigational Site
Caen, France, 14033
4
Pfizer Investigational Site
Clermont-Ferrand, France, 63003