drugset / Trial / 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

NCT00851721

Phase 3 Completed 52 enrolled Baxalta now part of Shire
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-03-31
Primary completion
2012-10-17
Completion
2012-10-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Factor VIII Inhibitor Bypassing Activity Unknown 85 iu/kg