3 results
To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…
The study will be performed in 2 parts, Part 1 and Part 2. Part 2 has been clinically completed. The remainder of this document concerns Part 1 only. The purpose of Part 1 of this study is to determine the reversal of the blood thinning effects of…
This study is being conducted to determine the safety and efficacy of the study drug BIVV001 when used as a once-a-week prophylaxis treatment or as an on-demand (as-needed) treatment for bleeding in patients 12 years and older with severe hemophilia…