NCT00851721

Efficacy and Safety Study of Prophylactic Versus On-Demand Treatment With Feiba NF in Subjects With Hemophilia A or B and a High Titer Inhibitor

FEIBA NF: A Prospective, Open-label, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Prophylactic Versus On-Demand Treatment in Subjects With Hemophilia A or B and a High Titer Inhibitor

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 4 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study was to determine the efficacy, safety, and health-related quality of life benefits with FEIBA NF prophylactic treatment as compared with on-demand treatment.

Conditions

• Hemophilia A or B With Inhibitors
• Hemophilia A
• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)	85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
BIOLOGICAL	Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated)	FEIBA NF dose and dosing interval as prescribed by the treating physician

Timeline

• Start date: 2009-03-31
• Primary completion: 2012-10-17
• Completion: 2012-10-17
• First posted: 2009-02-26
• Last updated: 2021-05-19
• Results posted: 2014-03-14

Locations

17 sites across 10 countries: United States, Brazil, Bulgaria, Croatia, Japan, New Zealand, Poland, Romania, Russia, Ukraine