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

This study is currently recruiting participants.
Verified July 2017 by Asahi Kasei Pharma America Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01598831
First Posted: May 15, 2012
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Asahi Kasei Pharma America Corporation
May 11, 2012
May 15, 2012
July 11, 2017
August 2012
September 2017   (Final data collection date for primary outcome measure)
  • Primary Efficacy Outcome Measure [ Time Frame: 28 days ]
    28 day all-cause mortality
  • Primary Safety Outcome Measure [ Time Frame: Through Study Day 28 ]
    Adverse Events
  • Primary Safety Outcome Measure [ Time Frame: Through Study Day 28 ]

    Major Bleeding Events defined below will be closely monitored and systematically collected as Serious Adverse Events:

    • any intracranial hemorrhage,
    • any life-threatening bleeding,
    • any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity),
    • or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days.6 (Investigator assessment for seriousness criteria.)
  • Primary Safety Outcome Measure [ Time Frame: Through Study Day 28 ]
    Serious Adverse Events
  • Primary Efficacy Outcome Measure [ Time Frame: 28 days ]
    28 day all-cause mortality
  • Primary Safety Outcome Measure [ Time Frame: 28 days ]
    Serious Adverse Events
  • Primary Safety Outcome Measure [ Time Frame: 28 days ]
    Major bleeding events
  • Primary Safety Outcome Measure [ Time Frame: 28 Days ]
    Adverse events
Complete list of historical versions of study NCT01598831 on ClinicalTrials.gov Archive Site
  • Secondary Efficacy Outcome Measure [ Time Frame: 3 months ]
    Follow up all-cause mortality at 3 months
  • Secondary Efficacy Outcome Measure [ Time Frame: 28 days ]
    Resolution of organ dysfunction as measured through day 28 by shock free, ventilator free, dialysis free plus alive days.
  • Secondary Safety Outcome Measure [ Time Frame: 18 months ]
    Presence of Anti-drug antibodies up to 18 months
Same as current
Not Provided
Not Provided
 
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy.
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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Severe Sepsis
  • Coagulopathy
  • Drug: ART-123
    Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
    Other Name: human recombinant thrombomodulin
  • Drug: Placebo
    Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.
  • Active Comparator: ART-123
    Intervention: Drug: ART-123
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
September 2018
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Scott Oshana 781-419-5039 info@akpamerica.com
Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Croatia,   Czechia,   Finland,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Korea, Republic of,   Netherlands,   New Zealand,   Peru,   Russian Federation,   Serbia,   Spain,   Taiwan,   Turkey,   United Kingdom,   United States
Czech Republic
 
NCT01598831
3-001
Yes
Not Provided
Not Provided
Asahi Kasei Pharma America Corporation
Asahi Kasei Pharma America Corporation
Not Provided
Study Director: David Fineberg, M.D. Asahi Kasei Pharma America Corporation
Asahi Kasei Pharma America Corporation
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP