Brief Title
BeneFIX Drug Use Results Survey [All-Case Surveillance]
Official Title
Benefix(Registered) Intravenous 500 1000 2000 Drug Use Results Survey (All-case Surveillance)
Brief Summary
The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch. 1. Occurrence status of adverse events 2. Factors that may influence the safety 3. Efficacy In addition, the following occurrence statuses will be investigated as priority items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic reaction, and Thrombosis.
Detailed Description
Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug. Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs"). The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."
Study Type
Observational
Primary Outcome
Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy
Secondary Outcome
Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes
Condition
Hemophilia B
Intervention
Nonacog Alfa (Genetical Recombination)
Study Arms / Comparison Groups
Nonacog Alfa (Genetical Recombination)
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
314
Start Date
February 2010
Completion Date
February 27, 2017
Primary Completion Date
August 2014
Eligibility Criteria
Inclusion Criteria: - All patients with hemophilia B scheduled to receive treatment with BeneFIX will be eligible for the surveillance. - No patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected. Exclusion Criteria: - Patients not administered BeneFIX.
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Japan
Location Countries
Japan
Administrative Informations
NCT ID
NCT01154231
Organization ID
3090X1-4415
Secondary IDs
B1821004
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
September 2018