Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B

Pfizer

Status: Completed

Conditions: Hemophilia B

Treatments: Drug: BeneFIX (coagulation factor IX (recombinant))

Study type: Observational

Funder types: Industry

Identifiers

NCT00484185

B1821005

3090X1-4403

Details and patient eligibility

About

To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including:

1. Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the incidences of adverse reactions under the routine drug uses.

2. Factors that may affect the safety of the drug 4) Factors that may affect the effectiveness of the drug

Full description

The patients who meet the inclusion criteria will be enrolled consecutively.

Enrollment: 183 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients or legally authorized representatives of pediatric patients agree to provide written informed consent form (data privacy statement).
• Pediatric and adult patients who have been treated with original or reformulated BeneFIX for hemophilia B (congenital factor IX deficiency or Christmas disease) from first approved date by KFDA, or who are planned to be newly prescribed BeneFIX (for example, patients switching from pdFIX to BeneFIX).

Exclusion criteria

• Patients with a known history of hypersensitivity to original or reformulated BeneFIX or any component of the product.
• Patients with a known history of hypersensitivity to hamster protein.
• Patients participating in an interventional trial of any investigational drug or device.

Trial design

183 participants in 1 patient group

1

Treatment:

Drug: BeneFIX (coagulation factor IX (recombinant))