Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asahi Kasei Pharma America Corporation

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 < 0.3 ml/kg/hr) > 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