NCT01154231

BeneFIX Drug Use Results Survey [All-Case Surveillance]

BENEFIX(REGISTERED) INTRAVENOUS 500 1000 2000 DRUG USE RESULTS SURVEY (ALL-CASE SURVEILLANCE)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 314 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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."

Conditions

• Hemophilia B

Interventions

Type	Name	Description
DRUG	Nonacog Alfa (Genetical Recombination)	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."

Timeline

• Start date: 2009-10-29
• Primary completion: 2014-08-29
• Completion: 2017-02-27
• First posted: 2010-06-30
• Last updated: 2025-07-16
• Results posted: 2017-04-11

Locations

1 site across 1 country: Japan