INdividualized ITI Based on Fviii(ATE) Protection by VWF

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 \[≥5 Bethesda Unit (BU)\].

Timeline

Start

2017-06-01

Primary completion

2019-07-19

Completion

2019-07-19

Drugs

Indications