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

Asahi Kasei Medical

Status and phase

Completed

Phase 3

Conditions

Coagulopathy

Severe Sepsis

Treatments

Drug: Placebo

Drug: ART-123

Study type

Interventional

Funder types

Industry

Identifiers

NCT01598831

3-001

Details and patient eligibility

About

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

Full description

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.

Enrollment

816 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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