MEDI8111 / AstraZeneca - LARVOL DELTA

To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses. (clinicaltrials.gov) - P1; N=48; Recruiting; Sponsor: AstraZeneca; N=62 -> 48

Enrollment change • Biosimilar

Recombinant human prothrombin (MEDI8111) combined with fibrinogen dose-dependently improved survival time and reduced blood loss in a porcine model of dilutional coagulopathy with uncontrolled bleeding. (PubMed, Blood Coagul Fibrinolysis) - "Administration of fibrinogen and MEDI8111 was sufficient to improve survival time and haemostasis in severely coagulopathic pigs. The dose-dependent haemostatic improvement observed with MEDI8111 administration suggests that prothrombin concentration was rate limiting for coagulation."

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