NCT02234323

An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Bioverativ, a Sanofi company · Industry
• Sex: Male
• Age: 5 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	rFVIIIFc	Administered as specified in arm description

Timeline

• Start date: 2015-01-12
• Primary completion: 2019-09-23
• Completion: 2019-09-23
• First posted: 2014-09-09
• Last updated: 2022-04-11
• Results posted: 2020-08-13

Locations

71 sites across 14 countries: United States, Australia, Brazil, Canada, France, Germany, Ireland, Italy, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom