Study Evaluating rFIX; BeneFIX® in Hemophilia B

Wyeth

Status and phase: Completed; Phase 3

Conditions: Hemophilia B

Treatments: Drug: rFIX

Study type: Interventional

Funder types: Industry

Identifiers

NCT00093171

3090A1-302

Details and patient eligibility

About

The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).

Enrollment: 23 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemophilia B (FIX:C less than 2%)
• Previous treatment of at least 150 exposure days using any FIX product
• 12 years of age and older

Exclusion criteria

• The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
• Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
• Patient has a genetic coagulation disorder other than hemophilia B