NCT01425723

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

An Open-Label, Multicenter, Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Bioverativ Therapeutics Inc. · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

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 prevention and treatment of bleeding episodes.

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 (NCT01027364) and Kids B-LONG study 9HB02PED (NCT01440946)

Conditions

• Severe Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	rFIXFc	Administered as specified in the treatment arm.

Timeline

• Start date: 2011-12-08
• Primary completion: 2017-10-01
• Completion: 2017-10-01
• First posted: 2011-08-30
• Last updated: 2020-12-19
• Results posted: 2018-11-23

Locations

49 sites across 18 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Netherlands, Poland, South Africa, Sweden, United Kingdom