phase 3 safety and efficacy study of art-123 in subjects with severe sepsis and coagulopathy

Conditions: Severe Sepsis; Coagulopathy

Summary: the purpose of the study is to evaluate if art-123 given to patients who have severe sepsis can decrease mortality.

study is to evaluate if art-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality.

Eligibility criteria:
inclusion criteria: * subject must be receiving treatment in an icu, or in an acute care setting (e.g., er, rr) * clinical objective evidence of bacterial infection and a known site of infection. * cardiovascular dysfunction or respiratory failure due to sepsis. * coagulopathy characterized by an inr \>1.40 without other known causes. exclusion criteria: * subject or authorized representative is unable to provide informed consent. * subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study. * subject is of childbearing potential and does not have a negative pregnancy test. * subject is \< 18 years of age. * subject has a known allergy to art-123 or any components of the drug product. * subject is unwilling to allow transfusion of blood or blood products. * subject has an advance directive to withhold life-sustaining treatment. * subject has had previous treatment with art-123. * body weight ≥ 175 kg. * platelets \< 30,000/ mm3 for any reason, pt prolongation or thrombocytopenia that is not due to sepsis. * any surgery that is potentially hemorrhagic (e.g. intra-thoracic, intra-abdominal or non-traumatic orthopedic surgery of the femur or pelvis) that is completed within 12 hours prior to first dose of study drug, or ongoing impairment of hemostasis as a result of one of these procedures * history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to consent. * cerebral vascular accident (cva) within 3 months prior to consent. * any history of intracerebral arteriovenous malformation (avm), cerebral aneurysm, or mass lesions of the central nervous system. * history of congenital bleeding diathesesor anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia). * significant gastrointestinal bleeding within 6 weeks prior to consent. * subject is diagnosed with a known medical condition associated with a hypercoagulable state. * child-pugh score of 10-15 (class c) * portosystemic hypertension or known history of bleeding esophageal varices. * history of solid organ, allogeneic bone marrow, or stem cell transplantation within the 6 months prior to consent. * acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture or gram stain consistent with bacterial infection. * subjects with renal dysfunction defined as (a) chronic renal failure requiring renal replacement therapy (rrt), or (b) acute renal failure with onset of oliguria (urine output \ 48 hours prior to first dose of study drug whether receiving rrt or not * use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 72 hours prior to first does of study drug. * life expectancy \< 90 days. * current use of any chemotherapy agent likely to cause myeloablation (severe or complete depletion of bone marrow). * participation in another research study involving an investigational agent within 30 days prior to consent or projected study participation during the 28 days post study randomization. * confirmed or suspected endocarditis

Keywords: sepsis