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Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B
Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B

NCT01425723

CompletedPhase 3

Sponsor: Bioverativ Therapeutics Inc.

Conditions: Severe Hemophilia B

Interventions: rFIXFc

Countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany

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 prevention and treatment of bleeding episodes.

Eligibility overview

Sex: MALE

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* 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 Criteria:

* High-titer inhibitor (\>/=5.00 BU/mL)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Locations (49)
  • Phoenix, Arizona, United States
  • Sacramento, California, United States
  • Aurora, Colorado, United States
  • Atlanta, Georgia, United States
  • Honolulu, Hawaii, United States
  • Indianapolis, Indiana, United States
  • New Orleans, Louisiana, United States
  • East Lansing, Michigan, United States
  • Pittsburgh, Pennsylvania, United States
  • Seattle, Washington, United States
  • Adelaide, South Australia, Australia
  • Parkville, Victoria, Australia
  • Murdoch, Western Australia, Australia
  • Perth, Western Australia, Australia
  • Brussels, Belgium
  • Leuven, Belgium
  • Campinas, São Paulo, Brazil
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Beijing, Beijingshì, China
  • Guangzhou, Guangdongsheng, China
  • Shanghai, Shànghaishì, China
  • Tianjing, Tianjinshì, China
  • Marseille, Bouches-Du-Rhône, France
  • Bonn, North Rhine-Westphalia, Germany
  • Hong Kong, New Territories, Hong Kong
  • Hong Kong, Hong Kong
  • Bangalore, Karnataka, India
  • Pune, Maharashtra, India
  • Vellore, Tamil Nadu, India
  • + 19 more on CT.gov