BeneFIX Drug Use Results Survey [All-Case Surveillance]

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Hemophilia B

Clinical Trial Details

NCT number	NCT01154231
Study type	Observational
Source	Pfizer
Contact
Status	Completed
Phase
Start date	February 2010
Completion date	February 27, 2017

View Details

See also
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