Post Marketing Observational Study of Reformulated BeneFIX
Post Marketing Observational Study Of Reformulated BeneFIX
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.
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) Prior to Safety Amendment
Number of Bleeding Episodes
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
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).
N/A - N/A
Accepts Healthy Volunteers
Pfizer CT.gov Call Center, ,
Pfizer CT.gov Call Center, Study Director, Pfizer