hat PCC was well-tolerated in patients and that the incidences of severe treatment-emergent adverse events, serious adverse events and deaths were generally similar between the PCC and plasma groups. Also, PCC was shown to possibly reduce the risk of transfusion-associated circulatory overload – that is, when too much fluid is transfused or transfusion is too rapid, which can lead to cardiac events – when compared to plasma (8.7 percent compared to 19.3 percent, respectively).
"We are very encouraged by the results, as this is the first and largest randomized clinical study showing 4-factor PCC is highly effective in reducing INR and increasing factor levels to support hemostatic efficacy during warfarin-induced bleeding," said Russell Basser, M.D., Senior Vice President, Global Clinical R&D, at CSL Behring. "CSL Behring is advancing our investigational 4-factor PCC through rigorous clinical study with the goal of bringing to the United States a safe, effective new treatment option for people who are at risk of major bleeding that results from warfarin use."
About Prothrombin Complex Concentrate (PCC) (Human)
Prothrombin complex concentrates (PCC) are derived from human plasma. CSL Behring's investigational PCC contains four important pro-coagulant factors in significant quantities: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as anticoagulant Proteins C and S.
Guidelines from the American College of Chest Physicians recommend 4-factor PCC, rather than plasma, for rapid reversal of anticoagulation in patients with vitamin K antagonist associated major bleeding. The guidelines also recommend the use of vitamin K (5 to 10 mg) administered by slow intravenous (IV) infusion rather than reversal with coagulation factors alone.
About the Study
This was an open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of human 4-factoPage: 1 2 3 4 Related biology technology :1
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