Immunopharmacology & Hematologic Pharmacology | Methods for Diagnostic & Therapeutic Studies | Bleeding & Coagulation Disorders
Integrated safety analysis of a 4-factor prothrombin complex concentrate versus plasma in Phase III clinical trials
Ravi Sarode, Truman J Milling, Majed A Refaai, Antoinette Mangione*, Billie L Durn, Joshua N Goldstein
*Corresponding author: Antoinette Mangione
CSL Behring, King of Prussia, PA, USA
F1000Posters 2012, 3: 555 (poster) [English]
Poster [356.19 KB]
Thrombosis and Hemostasis Summit of North America (THSNA) 2012, 3 - 5 May 2012, D18
These integrated safety data represent the first controlled assessment of a prothrombin complex concentrate (PCC) compared to plasma using significant numbers of subjects.
Overall, this 4-factor PCC was safe and well-tolerated, with a safety profile at least as good as plasma, for subjects receiving vitamin K antagonists (VKAs) and who require urgent replacement of vitamin K-dependent clotting factors.
Corresponding author Antoinette Mangione and coauthor Billie L Durn are paid employees of CSL Behring.
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