Brief Title
Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
Official Title
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=2%)
Brief Summary
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Annualized Number of Bleeding Episodes.
Secondary Outcome
Response to On-Demand Treatment for All Bleeding Episodes.
Condition
Hemophilia B
Intervention
Nonacog alfa
Study Arms / Comparison Groups
BeneFIX
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
25
Start Date
September 2011
Completion Date
April 2014
Primary Completion Date
April 2014
Eligibility Criteria
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.
Gender
Male
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Pfizer CT.gov Call Center, ,
Location Countries
Bulgaria
Location Countries
Bulgaria
Administrative Informations
NCT ID
NCT01335061
Organization ID
B1821010
Secondary IDs
3090A1-3306
Responsible Party
Sponsor
Study Sponsor
Pfizer
Study Sponsor
Pfizer CT.gov Call Center, Study Director, Pfizer
Verification Date
May 2015