Brief Title
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha® In Subjects With Hemophilia A
Official Title
Post Marketing Surveillance To Observe Safety And Efficacy Of Xyntha 'Registered' In Subjects With Hemophilia A
Brief Summary
This study is to describe the safety and efficacy of Xyntha® during the usual care setting.
Detailed Description
non probability sample
Study Type
Observational
Primary Outcome
Percentage of Participants by Family History of Factor VIII Inhibitor
Secondary Outcome
Number of Xyntha Infusions Used to Treat Each New Bleed for On-Demand Therapy (All Participants)
Condition
Hemophilia A
Intervention
Xyntha : coagulation factor IIIV (recombinant)
Study Arms / Comparison Groups
Xyntha group
Description: Xyntha will be administered according to physician's discretion.
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
42
Start Date
February 2014
Completion Date
August 2014
Primary Completion Date
August 2014
Eligibility Criteria
Inclusion Criteria: - Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement). - Pediatric and adult patients who have been treated with Xyntha for Hemophilia A from first approved date by KFDA, or who are planned to be newly prescribed Xyntha. Exclusion Criteria: - Patients with a known history of hypersensitivity to original or reformulated Xyntha or any component of the product. - Patients with a known history of hypersensitivity to hamster protein. - Patients participating in an interventional trial of any investigational drug or device.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01790828
Organization ID
B1831078
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
July 2015