NCT02392156

Fc factOrs and Real-World hemophiliA Patient-ReporteD Outcomes

A Global, Multicenter, Observational Study Evaluating the Impact of rFVIIIFc and rFIXFc on Patient-reported Treatment Burden and Health Economic Outcomes

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

Summary

The primary objective of the study is to evaluate the effectiveness of prophylactic treatment with recombinant Factor VIII Fc fusion protein (rFVIIIFc) and recombinant Factor IX Fc fusion protein (rFIXFc) therapy as assessed by patient treatment burden and health economic outcomes while maintaining disease control in males with hemophilia A or B.

Conditions

• Hemophilia A
• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	rFVIIIFc	As described in the treatment arm
BIOLOGICAL	rFIXFc	As described in the treatment arm
DRUG	non-Fc FVIII replacement products	Standard plasma-derived (pd) or recombinant (r) FVIII concentrate and other traditional treatment options
DRUG	non-Fc FIX replacement products	Standard plasma-derived (pd) or recombinant (r) FIX concentrate and other traditional treatment options

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-03-18
• Last updated: 2020-12-19

Locations

2 sites across 1 country: United States