NCT02234310

Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor IX Fc Fusion Protein (rFIXFc; BIIB029) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia B

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Bioverativ, a Sanofi company · Industry
• Sex: Male
• Age: 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	rFIXFc	Adjustments to the dose and interval of rFIXFc was made in this study based on investigator discretion using available pharmacokinetic (PK) data, subsequent FIX trough and peak levels, level of physical activity, and bleeding pattern, in accordance with local standards of care for a prophylactic regimen. There was an option to start study dosing as episodic treatment (on-demand).

Timeline

• Start date: 2014-11-13
• Primary completion: 2019-08-20
• Completion: 2019-08-20
• First posted: 2014-09-09
• Last updated: 2022-03-25
• Results posted: 2020-07-31

Locations

27 sites across 11 countries: United States, Australia, Denmark, France, Ireland, Italy, Netherlands, New Zealand, Poland, Sweden, United Kingdom