Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B
Completed · Phase 3
Conditions studied: Hemophilia B
In brief
The primary objective of the study was to evaluate the safety of recombinant coagulation factor IX Fc fusion protein (rFIXFc, BIIB029) in previously untreated patients (PUPs) with severe hemophilia B. Secondary objectives were to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes in PUPs, and to evaluate rFIXFc consumption for prevention and treatment of bleeding episodes in PUPs.
Key facts
- Study ID
- NCT02234310
- Run by
- Bioverativ, a Sanofi company
- People needed
- 33
- Starts
- 2014-11-13
- Expected to finish
- 2019-08-20
- Last updated by the study team
- 2022-03-25
Who can join
Age: any, up to 17. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Research Site — Sacramento, California, United States
- Research Site — Washington D.C., District of Columbia, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Indianapolis, Indiana, United States
- Research Site — Louisville, Kentucky, United States
- Research Site — New Orleans, Louisiana, United States
- Research Site — East Lansing, Michigan, United States
- Research Site — Traverse City, Michigan, United States
- Research Site — Columbus, Ohio, United States
- Research Site — Portland, Oregon, United States
- Research Site — Pittsburgh, Pennsylvania, United States
- Research Site — Westmead, New South Wales, Australia
- Research Site — Aarhus, Denmark
- Hopital Cardiologique - CHU Lille — Lille, Nord, France
- Research Site — Lyon, Rhone, France
- Research Site — Dublin, Ireland
- Research Site — Milan, Italy
- Research Site — Naples, Italy
- Research Site — Parma, Italy
- Research Site — Roma, Italy
- Research Site — Utrecht, Netherlands
- Research Site — Auckland, New Zealand
- Research Site — Warsaw, Poland
- Research Site — Malmö, Sweden
- Research Site — Cambridge, Cambridgeshire, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.