Trial record 2 of 4 for:    ART-123

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

This study is currently recruiting participants.
Verified February 2014 by Asahi Kasei Pharma America Corporation
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma America Corporation
ClinicalTrials.gov Identifier:
NCT01598831
First received: May 11, 2012
Last updated: February 3, 2014
Last verified: February 2014

May 11, 2012
February 3, 2014
August 2012
March 2015   (final data collection date for primary outcome measure)
  • Primary Efficacy Outcome Measure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    28 day all-cause mortality
  • Primary Safety Outcome Measure [ Time Frame: Through Study Day 28 ] [ Designated as safety issue: Yes ]
    Adverse Events
  • Primary Safety Outcome Measure [ Time Frame: Through Study Day 28 ] [ Designated as safety issue: Yes ]

    Major Bleeding events defined as:

    • any intracranial hemorrhage, (Qualifies as a Serious Adverse Event)
    • any life-threatening bleeding, (Qualifies as a Serious Adverse Event)
    • any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), (Qualifies as a Serious Adverse Event)
    • or any bleeding that required the administration of 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 ] [ Designated as safety issue: Yes ]
    Serious Adverse Events
Same as current
Complete list of historical versions of study NCT01598831 on ClinicalTrials.gov Archive Site
  • Secondary Efficacy Outcome Measure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Follow up all-cause mortality at 3 months
  • Secondary Efficacy Outcome Measure [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
March 2016
March 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subject must be receiving treatment in an ICU, or in an acute care setting with orders to transfer to ICU.
  • Clinical 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.
  • PT prolongation or thrombocytopenia that is not due to sepsis.
  • Intra-thoracic or intra-abdominal surgery within 12 hours prior to consent, or ongoing bleeding issues 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 diatheses.
  • 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.
  • Severe renal failure requiring chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis.
  • Use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 72 hours prior to consent.
  • 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.
Both
18 Years and older
No
Contact: Matt Mockler 781-419-1919 info@akpamerica.com
United States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Colombia,   Croatia,   Czech Republic,   Finland,   France,   Germany,   Hungary,   India,   Israel,   Netherlands,   New Zealand,   Peru,   Serbia,   Spain,   United Kingdom
 
NCT01598831
3-001
Yes
Asahi Kasei Pharma America Corporation
Asahi Kasei Pharma America Corporation
Not Provided
Study Director: Inder Kaul, M.D., MPH Asahi Kasei Pharma America Corporation
Asahi Kasei Pharma America Corporation
February 2014

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