Brief Title
Registry For Patients Treated With BeneFix In Usual Care Setting In Germany
Official Title
Pharmacovigilance Evaluation Of Benefix (Registered) In Germany And Austria
Brief Summary
The purpose of this observational study is to describe the incidence of adverse events among patients treated with BeneFix® in usual health care settings in Germany.
Detailed Description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
Study Type
Observational
Primary Outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Secondary Outcome
Mean Total Number of Bleeding Episodes in Participants
Condition
Hemophilia B
Intervention
BeneFIX
Study Arms / Comparison Groups
A
Description: Patients with Hemophilia B
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
Drug
Estimated Enrollment
80
Start Date
January 2008
Completion Date
October 2016
Primary Completion Date
October 2016
Eligibility Criteria
Inclusion Criteria: - Patients with hemophilia B already receiving or starting treatment with reformulated BeneFIX®. Exclusion Criteria: - Patients with hemophilia B treated with a product other than BeneFIX®. - Inclusion in the ongoing prospective registry of European hemophilia B patients using BeneFIX®.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00714415
Organization ID
3090A1-4406
Secondary IDs
B1821011
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
September 2018