Post Marketing Observational Study of Reformulated BeneFIX

Pfizer

Status: Completed

Conditions: Hemophilia B

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT00835068

3090X1-4409

B1821007

Details and patient eligibility

About

The primary objective of this observational study is to collect safety data on reformulated BeneFIX as prescribed in routine clinical practice conditions in France. The secondary objectives are to collect data on the clinical course of individuals treated with reformulated BeneFIX and on the ease of reformulated BeneFIX.

Full description

No sampling

Enrollment: 58 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with Hemophilia B already receiving or starting treatment with reformulated BeneFIX.
• Subjects who have dated and signed the informed consent form.

Exclusion criteria

• Ongoing treatment of Hemophilia B by a product other than reformulated BeneFIX.
• Participation in the European prospective registry of patients with Hemophilia B treated with BeneFIX (Wyeth protocol 3090A-101039).

Trial design

58 participants in 1 patient group

BeneFIX

Treatment:

Other: No intervention