BeneFIX Drug Use Results Survey [All-Case Surveillance]

Completed

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."

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Nonacog Alfa (Genetical Recombination)	Nonacog Alfa (Genetical Recombination)	-

Primary Outcome Measures

Name	Time	Method
Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy	2 years for PTPs, 1 year for PUPs	Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing.
Number of Administrations Required for Hemostasis for Bleeding Events	2 years for PTPs, 1 year for PUPs	Mean number of administrations for hemostasis in replacement therapy for bleeding events.

Secondary Outcome Measures

Name	Time	Method
Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes	2 years for PTPs, 1 year for PUPs	Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated.