Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B
Completed · Phase 3
Conditions studied: Hemophilia B
In brief
The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B. Secondary objectives of this study in this study population are as follows: to evaluate the efficacy of rFIXFc for prevention and treatment of bleeding episodes; to evaluate and assess the pharmacokinetics (PK) of rFIXFc; to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes
Key facts
- Study ID
- NCT01440946
- Run by
- Bioverativ Therapeutics Inc.
- People needed
- 30
- Starts
- 2012-06-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2020-12-19
Who can join
Age: any, up to 11. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Research Site — Phoenix, Arizona, United States
- Research Site — Sacramento, California, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Honolulu, Hawaii, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — East Lansing, Michigan, United States
- Research Site — Pittsburgh, Pennsylvania, United States
- Research Site — Parkville, Victoria, Australia
- Research Site — Subiaco, Western Australia, Australia
- Research Site — Dublin, Ireland
- Research Site — Utrecht, Netherlands
- Research Site — Johannesburg, South Africa
- Research Site — Basingstoke, United Kingdom
- Research Site — Cambridge, United Kingdom
- Research Site — London, United Kingdom
Full record on ClinicalTrials.gov
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