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



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - 65
Updated:3/30/2013
Start Date:September 2011
End Date:May 2014
Contact:Pfizer CT.gov Call Center
Phone:1-800-718-1021

Use our guide to learn which trials are right for you!

A Multicenter, Open-Label Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of Nonacog-Alfa (BeneFIX) In Subjects With Moderately Severe To Severe Hemophilia B (FIX:C

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.


Inclusion Criteria:

- Documented history of moderately-severe to severe hemophilia B (FIX activity
- 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.
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
Click here to add this to my saved trials