BeneFIX Drug Use Results Survey [All-Case Surveillance]

Pfizer

Status: Completed

Conditions: Hemophilia B

Treatments: Drug: Nonacog Alfa (Genetical Recombination)

Study type: Observational

Funder types: Industry

Identifiers

NCT01154231

3090X1-4415

B1821009 (Other Identifier)

Details and patient eligibility

About

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.

Full 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."

Enrollment: 314 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

314 participants in 1 patient group

Nonacog Alfa (Genetical Recombination)

Treatment:

Drug: Nonacog Alfa (Genetical Recombination)