Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
Purpose
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
Conditions
- Severe Sepsis
- Coagulopathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator ART-123 |
|
|
|
Placebo Comparator Placebo |
|
More Details
- Status
- Completed
- Sponsor
- Asahi Kasei Pharma America Corporation
Study Contact
Detailed 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.