Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B

Pfizer

Status and phase

Completed

Phase 3

Conditions

Hemophilia B

Treatments

Biological: Nonacog alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT01335061

2011-000520-15 (EudraCT Number)

B1821010

3090A1-3306 (Other Identifier)

Details and patient eligibility

About

The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.

Enrollment

25 patients

Sex

Male

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Documented history of moderately-severe to severe hemophilia B (FIX activity </=2%).
Male subjects, aged 12 years to 65 years.
Subjects with at least 100 exposure days (EDs) to factor IX products.
Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12-month period before the Screening visit.

Exclusion criteria

Subjects who have received FIX as a primary or secondary prophylaxis regimen within the last 12 months prior to the Screening visit.
Subjects who have had major surgery or an orthopedic surgical procedure within the past 3 months prior to Screening visit.
Subjects for which major surgery or orthopedic surgery is planned within the duration of study participation.
Subjects with a past history of, or current FIX inhibitor, defined as >ULN (upper limit of normal) of the reporting laboratory.
Subjects with a known hypersensitivity to any FIX product or hamster protein.