Brief Title
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
Official Title
Post Marketing Surveillance To Observe Safety And Efficacy Of BeneFIX In Patients With Hemophilia B
Brief Summary
To provide safety and effectiveness information of BeneFIX during the post-marketing period
as required by Korea FDA regulations, to identify any potential drug related treatment
factors in Korean population including:
1) Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the
incidences of adverse reactions under the routine drug uses.
3) Factors that may affect the safety of the drug 4) Factors that may affect the
effectiveness of the drug
Detailed Description
The patients who meet the inclusion criteria will be enrolled consecutively.
Study Type
Observational
Primary Outcome
Number of Participants With Adverse Events (AEs) According to Baseline Characteristics
Secondary Outcome
Mean Annualized Bleeding Rate (ABR)
Condition
Hemophilia B
Intervention
BeneFIX (coagulation factor IX (recombinant))
Study Arms / Comparison Groups
1
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
Drug
Estimated Enrollment
183
Start Date
August 2007
Completion Date
June 2012
Primary Completion Date
June 2012
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 original or reformulated
BeneFIX for hemophilia B (congenital factor IX deficiency or Christmas disease) from
first approved date by KFDA, or who are planned to be newly prescribed BeneFIX (for
example, patients switching from pdFIX to BeneFIX).
Exclusion Criteria:
- Patients with a known history of hypersensitivity to original or reformulated BeneFIX
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
NCT00484185
Organization ID
3090X1-4403
Secondary IDs
B1821005
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
May 2013