An Open Enrollment Study of Factor XIII Concentrate in Subjects With Congenital Factor XIII Deficiency

Congenital deficiency of factor XIII is an extremely rare inherited disorder associated with
potentially life-threatening bleeding. Factor XIII Concentrate is given to patients whose
blood is lacking factor XIII. Factor XIII Concentrate works by assisting blood in the usual
clotting process, thereby preventing bleeding.

In this study, patients will be treated with FXIII Concentrate and followed closely to
determine that they receive the dose of FXIII Concentrate that will best minimize the chance
of bruising and bleeding. The purpose of the study is to provide FXIII Concentrate to
patients until the product becomes commercially available in the United States.