INdividualized ITI Based on Fviii(ATE) Protection by VWF
Status:
Terminated
Trial end date:
2019-07-19
Target enrollment:
Participant gender:
Summary
The primary goal of the INITIATE trial is to compare the clinical outcome of individualized
lot selection to random lot selection utilizing one plasma-derived von Willebrand factor
(VWF)/coagulation factor (FVIII) complex concentrate for immune tolerance induction (ITI) in
subjects with congenital Hemophilia A, FVIII activity ≤2%, and a historical high-titer
inhibitor [≥5 Bethesda Unit (BU)].