Status:
COMPLETED
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
Lead Sponsor:
Bioverativ Therapeutics Inc.
Conditions:
Severe Hemophilia B
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B. The secondary objective of this study is to evaluate the efficacy of rFIXFc in the ...
Detailed Description
Participants will follow either a prophylaxis or on-demand regimen. The starting dose in this study will be determined by the clinical profile of the patient in the preceding studies, B-LONG 998HB102 ...
Eligibility Criteria
Inclusion
- Key
- Subjects who have completed studies 998HB102 (NCT01027364) or 9HB02PED (NCT01440946) or other studies with rFIXFc
- Ability to understand the purposes \& risks of the study and provide signed and dated informed consent.
- Key
Exclusion
- High-titer inhibitor (\>/=5.00 BU/mL)
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Key Trial Info
Start Date :
December 8 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01425723
Start Date
December 8 2011
End Date
October 1 2017
Last Update
December 19 2020
Active Locations (49)
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1
Research Site
Phoenix, Arizona, United States, 85016
2
Research Site
Sacramento, California, United States, 95817
3
Research Site
Aurora, Colorado, United States, 80045
4
Research Site
Atlanta, Georgia, United States, 30322