Brief Title
Post Marketing Observational Study of Reformulated BeneFIX
Official Title
Post Marketing Observational Study Of Reformulated BeneFIX
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 collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.
Detailed Description
No sampling
Study Type
Observational
Primary Outcome
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
Secondary Outcome
Number of Bleeding Episodes
Condition
Hemophilia B
Intervention
No intervention
Study Arms / Comparison Groups
BeneFIX
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
58
Start Date
January 2009
Completion Date
October 2013
Primary Completion Date
October 2013
Eligibility Criteria
Inclusion Criteria: - Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX. - Subjects who have dated and signed the informed consent form. Exclusion Criteria: - 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).
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00835068
Organization ID
3090X1-4409
Secondary IDs
B1821007
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
September 2014