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Trial record 2 of 6 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. (see Contacts and Locations)
Verified August 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: August 25, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Severe Sepsis
Coagulopathy
Drug: ART-123
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Asahi Kasei Pharma America Corporation:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 800
Study Start Date: August 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ART-123 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
Placebo Comparator: Placebo Drug: Placebo
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  • Any surgery that is potentially hemorrhagic (e.g. intra-thoracic, intra-abdominal or non-traumatic orthopedic surgery of the femur or pelvis) 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 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.
  • Subjects with renal dysfunction defined as (a) Chronic renal failure requiring renal replacement therapy (RRT), or (b) Subjects with sepsis induced renal dysfunction (average urine output < 0.3 ml/kg/hr) for greater than 36 hours prior to first qualifying INR whether receiving RRT or not.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01598831

Contacts
Contact: Matt Mockler 781-419-1919 info@akpamerica.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
Recruiting
Mobile, Alabama, United States
United States, Arizona
Recruiting
Phoenix, Arizona, United States
United States, California
Recruiting
Colton, California, United States
Recruiting
Los Angeles, California, United States
Recruiting
Sacramento, California, United States
Recruiting
San Diego, California, United States
United States, Delaware
Withdrawn
Newark, Delaware, United States, 19718
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Withdrawn
Clearwater, Florida, United States, 33756
Withdrawn
Orlando, Florida, United States, 32804
United States, Idaho
Recruiting
Idaho Falls, Idaho, United States
United States, Illinois
1 of 2 Recruiting
Chicago, Illinois, United States, 60612
2 of 2 Recruiting
Chicago, Illinois, United States, 60611
Withdrawn
Oak Park, Illinois, United States, 60302
Recruiting
Peoria, Illinois, United States
United States, Iowa
Withdrawn
Iowa City, Iowa, United States, 52242
United States, Kansas
Recruiting
Topeka, Kansas, United States
United States, Kentucky
Recruiting
Hazard, Kentucky, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
United States, Massachusetts
Withdrawn
Springfield, Massachusetts, United States, 01199
Withdrawn
Worcester, Massachusetts, United States, 01655
United States, Mississippi
Recruiting
Jackson, Mississippi, United States
United States, Missouri
Recruiting
St. Louis, Missouri, United States
United States, Montana
Recruiting
Butte, Montana, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, New Jersey
Recruiting
Camden, New Jersey, United States
Recruiting
Englewood, New Jersey, United States
United States, New York
Recruiting
Mineola, New York, United States
United States, North Carolina
Recruiting
Asheville, North Carolina, United States
Withdrawn
Chapel Hill, North Carolina, United States, 27599
Terminated
Durham, North Carolina, United States, 27710
Withdrawn
Greensboro, North Carolina, United States, 27403
Recruiting
Greenville, North Carolina, United States
Recruiting
Winston-Salem, North Carolina, United States
United States, Ohio
Recruiting
Cleveland, Ohio, United States
Recruiting
Colombus, Ohio, United States
Recruiting
Toledo, Ohio, United States
United States, Oklahoma
Recruiting
Oklahoma City, Oklahoma, United States
United States, Oregon
Withdrawn
Portland, Oregon, United States, 97239
United States, South Dakota
Recruiting
Rapid City, South Dakota, United States
United States, Texas
Withdrawn
Austin, Texas, United States, 78752
1 of 2 Recruiting
Houston, Texas, United States
2 of 2 Recruiting
Houston, Texas, United States
United States, Washington
Withdrawn
Everett, Washington, United States, 98206
Argentina
Instituto Medico Platense Withdrawn
La Plata, Buenos Aires, Argentina, B1900AVG
Sanatorio del Salvador Withdrawn
Cordoba, Argentina, X5004BCL
Hospital Privado Centro Médico de Cordoba Withdrawn
Cordoba, Argentina
Nuestra Señora de la Misericordia Withdrawn
Cordoba, Argentina, X5000JRD
Nuevo Hospital San Roque Withdrawn
Cordoba, Argentina
Hospital Italiano de Cordoba Active, not recruiting
Cordoba, Argentina, X5004BAL
Australia, Australian Capital Territory
Calvary Health Care ACT Recruiting
Bruce, Australian Capital Territory, Australia
Australia, New South Wales
Prince of Wales Hospital Recruiting
Randwick, New South Wales, Australia
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia
Not yet recruiting
Nambour, Queensland, Australia
Gold Coast Hospital Recruiting
Southport, Queensland, Australia
Princess Alexandra Hospital Recruiting
Woolongabba, Queensland, Australia
Australia, Victoria
Bendigo Hospital Recruiting
Bendigo, Victoria, Australia
Monash Medical Centre Recruiting
Clayton, Victoria, Australia
Western Hospital Recruiting
Footscray, Victoria, Australia
Austin Health Recruiting
Heidelberg, Victoria, Australia
Epworth Health Care Recruiting
Richmond, Victoria, Australia
Australia, Western Australia
Fremantle Hospital Recruiting
Fremantle, Western Australia, Australia
Belgium
UZ Antwerpen Recruiting
Antwerpen, Belgium
Hopitaux Iris Sud Recruiting
Brussels, Belgium
Hopital Erasme Recruiting
Brussels, Belgium
UCL St. Luc Recruiting
Brussels, Belgium
UZ Brussel Recruiting
Brussels, Belgium
CHU Brugmann Recruiting
Brussels, Belgium
Centre Hospitalier de Dinant Recruiting
Dinant, Belgium
UZ Gent Recruiting
Gent, Belgium
Clinique Saint-Pierre Recruiting
Ottignies, Belgium
UCL Mont-Godinne Recruiting
Yvoir, Belgium
Brazil
Santa Casa de Misericordia de Belo Horizonte Recruiting
Belo Horizonte, MG, Brazil
Fundaçao Faculdade Regional de Medicina Sao Jose do Rio Preto Recruiting
Sao Jose do Rio Preto, SP, Brazil
Hospital Alemão Oswaldo Cruz Recruiting
São Paulo, SP, Brazil
Hospital São Paulo - Associação Paulista para o Desenvolvimento da Medicina Recruiting
São Paulo, SP, Brazil
Assoc. Portuguesa de Beneficiência Hospital Sao Joaquim Withdrawn
São Paulo, Brazil, 01323-001
Bulgaria
Anesthesiology and Intensive Care Clinic, University Multiprofile Hospital For Active Treatment "Sveti Georgi", Plovdiv Recruiting
Plovdiv, Bulgaria
Department of Anesthesiology and Intensive Care Multiprofile Hospital For Active Treatment "Tokuda Hospital Sofia", Sofia Recruiting
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia Withdrawn
Sofia, Bulgaria, 1606
Anesthesiology and Intensive Care Clinic Withdrawn
Varna, Bulgaria, 9010
Canada, Alberta
2 of 2 Recruiting
Calgary, Alberta, Canada, T1Y 6J4
1 of 2 Recruiting
Calgary, Alberta, Canada, T2N 2T9
Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Terminated
Vancouver, British Columbia, Canada, V5Z 1M9
2 of 2 Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Recruiting
Victoria, British Columbia, Canada
1 of 2 Recruiting
Victoria, British Columbia, Canada, V8R-1J8
Canada, Manitoba
Withdrawn
Winnipeg, Manitoba, Canada, R3J-3M7
Withdrawn
Winnipeg, Manitoba, Canada, R3A 1R9
Recruiting
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
Recruiting
London, Ontario, Canada
2 of 2 Recruiting
Ottawa, Ontario, Canada, KIH 8L6
1 of 2 Recruiting
Ottawa, Ontario, Canada, KIH 8L6
Recruiting
Windsor, Ontario, Canada
Colombia
Hospital Pablo Tobon Uribe Recruiting
Medellin, Antioquia, Colombia
Oncomedica S.A. Recruiting
Monteria, Cordoba, Colombia
Fundacion Cardiovascular de Colombia Withdrawn
Bucaramanga, Santander, Colombia
Croatia
University Hospital for Infectious Diseases, Institute for Infectious medicine and neuroinfectology Withdrawn
Zagreb, Croatia, 10000
Clinical Hospital Center Zagreb, Medical ICU Recruiting
Zagreb, Croatia
Clinical Hospital Dubrava, Department of Anesthesiology and resuscitation Recruiting
Zagreb, Croatia
Czech Republic
University Hospital Brno, Department of Infectious Diseases Recruiting
Brno, Czech Republic
University Hospital Hradec Kralove, Department of Anaesthesiology, Resuscitation and Intensive Care Recruiting
Hradec Kralove, Czech Republic
Regional Hospital Kolin, a.s., Department of Anaesthesilogy and Resuscitation Withdrawn
Kolin, Czech Republic, 28002
University Hospital Motol, Department of Anaesthesiology and Resuscitation CHU 2nd FM and UH Motol Withdrawn
Prague, Czech Republic, 15006
University Hospital Kralovske Vinohrady, Department of Anesthesiology and Resuscitation Recruiting
Prague 10, Czech Republic
General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine Recruiting
Prague 2, Czech Republic
Masaryk´s Hospital Ustni nad Labem, o.z., Department of Infectious Diseases Recruiting
Usti nad Labem, Czech Republic
Regional Hospital T. Bati, PLC Recruiting
Zlin, Czech Republic, 762 75
Finland
Helsingin Yliopistollinen Keskussairaala (HYKS) (Helsinki University Central Hospital (HUCH)) Recruiting
Helsinki, Finland
Keski-Suomen Keskussairaala (Central Finland Central Hospital) Recruiting
Jyvaeskylae, Finland
Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital) Recruiting
Kuopio, Finland
Etela-Pohjanmaan Sairaanhoitopiiri - Seinajoen Keskussairaala (Seinajoki Central Hospital) Recruiting
Seinajoki, Finland
Tampereen Yliopistollinen Sairaala (Tampere University Hospital) (TAYS) - Keskussairaala (Central Hospital) Recruiting
Tampere, Finland
France
CHU D'Anger Recruiting
Angers Cedex 9, France
CHU de Dijon, Hopital Bocage Central Recruiting
Dijon, France
CH-Hôpital Albert Michallon Recruiting
Grenoble cedex 09, France
Centre Hospitalier Départemental de Vendée-Les Oudairies Recruiting
La Roche-Sur-Yon cedex 9, France
Hôpital de Bicêtre - APHP Recruiting
Le Kremlin-Bicêtre, France
CHU Limoges Recruiting
Limoges cedex, France
Centre Hospitalier Universitaire Nîmes Recruiting
Nîmes Cedex 9, France
CHR Orléans, Hopital La Source Recruiting
Orléans, France
La Pitié Salpétrière, Paris Recruiting
Paris, France
CH Lyon Sud Recruiting
Pierre-Bénite cedex, France
Centre Hospitalier Universitaire de Poitiers Recruiting
Poitiers cedex, France, 86021
CH Angouleme, Saint Michel Recruiting
Saint Michel, France
Hôpital Rangueil Recruiting
Toulouse, France
CHU Tours, Hopital Bretonneau Recruiting
Tours, France
Germany
Charitè Campus Mitte Recruiting
Berlin, Germany
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany
Helios Klinikum Erfurt Recruiting
Erfurt, Germany
Klinikum der Johann-Wolfgang Goethe-Universität Recruiting
Frankfurt am Main, Germany
Universitätsklinikum Jena Recruiting
Jena, Germany
Klinikum Harlaching Recruiting
München, Germany
Evangelisches Krankenhaus Witten Withdrawn
Witten, Germany, 58455
Hungary
Szent Imre Hospital, Anesthesiology and Intensive Care Unit Terminated
Budapest, Hungary, 1115
Szent Janos Hospital and Unified Hospitals of North Buda - Szent Janos Hospital; Department of Anaesthesiology and Intensive Care Withdrawn
Budapest, Hungary, 1125
Medical Center of the University of Pecs; Department of Anesthesiology and Intensive Care Withdrawn
Pécs, Hungary, 7623
Department of Anesthesiology and Intensive Care, Albert Szent-Gyorgyi Clinical Center, University of Szeged Withdrawn
Szeged, Hungary, 6725
India
Maulana Azad Medical College and Associated L N Hospital Recruiting
New Delhi, Delhi, India
SUT Hospital Withdrawn
Trivandrum, Kerala, India, 695004
Deenanath Mangeshkar Hospital and Research Centre Recruiting
Pune, Maharashtra, India
King Edward Memorial Hospital & Research Centre Recruiting
Pune, Maharashtra, India
Hi-tech Medical College & Hospital Recruiting
Bhubaneswar, Odisha, India
Meenakshi Mission Hospital and Research Centre Recruiting
Madurai, Tamilnadu, India
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel
Hillel Yaffe Medical Center Withdrawn
Hadera, Israel, 38100
Rambam Medical Center Recruiting
Haifa, Israel
The Lady Davis Carmel Medical Center Recruiting
Haifa, Israel
Wolfson Medical Center Recruiting
Holon, Israel
Hadassah Ein Karen Medical Center Recruiting
Jerusalem, Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel
Kaplan Medical Center Recruiting
Rehovot, Israel
Netherlands
Jeroen Bosch Ziekenhuis Recruiting
's-Hertogenbosch, Netherlands
VUMC Recruiting
Amsterdam, Netherlands
Ziekenhuis Gelderse Vallei Recruiting
Ede, Netherlands
Medisch Spectrum Twente Recruiting
Enschede, Netherlands
University Medical Center Groningen Recruiting
Groningen, Netherlands
Atrium MC Heerlen Recruiting
Heerlen, Netherlands
Medisch Centrum Leeuwarden Recruiting
Leeuwarden, Netherlands
UMC St. Radboud Recruiting
Nijmegen, Netherlands
Ikazia Ziekenhuis Recruiting
Rotterdam, Netherlands
New Zealand
Auckland District Health Board Recruiting
Auckland, New Zealand
Christchurch Hospital Recruiting
Christchurch, New Zealand
Hawkes Bay Regional Hospital Intensive Care Unit Omahu Road Recruiting
Hastings, New Zealand
Wellington District Health Board Recruiting
Newtown, New Zealand, 6021
Waikato District Health Board Recruiting
Waikato, New Zealand
Peru
Hospital Nacional Almenara Yrigoyen - EsSALUD Recruiting
Lima, Lima Province, Peru
Hospital Nacional Arzobispo Loayza Recruiting
Lima, Lima Province, Peru
Hospital Nacional Edgardo Rebagliati Martins Recruiting
Lima, Lima Province, Peru
Hospital Nacional FAP Recruiting
Lima, Lima Province, Peru
Serbia
Clinical Centre Serbia,Center for Anestesiology and Reanimatology Recruiting
Belgrade, Serbia
Clinical Centre Serbia, Clinic of Neurology, Emergency Neurology Withdrawn
Belgrade, Serbia, 11000
Clinical Center Kragujevac, Center for Anesthesia and Reanimation Recruiting
Kragujevac, Serbia
Clinic for Infectious Diseases, Clinical Center Nis Recruiting
Nis, Serbia
Spain
Complexo Hospitalario Universitario A Coruña Recruiting
A Coruña, Spain
H. Universitario Príncipe de Asturias Recruiting
Alcalá de Henares, Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Universitari De Bellvitge Recruiting
Barcelona, Spain
Hospital de Gran Canaria Dr. Negrin Recruiting
Las Palmas de Gran Canaria, Spain
Clinica Moncloa Recruiting
Madrid, Spain, 28008
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Hospital de Sabadell Recruiting
Sabadell, Spain
Complejo Hospitalario Nuestra Señora de Valme Recruiting
Sevilla, Spain
Hospital Universitari de Tarragona Joan XXIII Recruiting
Tarragona, Spain
Hospital de Txagorritxu Recruiting
Vitoria, Spain
United Kingdom
James Paget University Hospital NHS Foundation Trust Recruiting
Great Yarmouth, United Kingdom
St. James's University Hospital Recruiting
Leeds, United Kingdom
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
St Thomas' Hospital Recruiting
London, United Kingdom, SE1 7EH
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Derriford Hospital Recruiting
Plymouth, United Kingdom
Musgrove Park Hospital Recruiting
Taunton, United Kingdom
Sponsors and Collaborators
Asahi Kasei Pharma America Corporation
Investigators
Study Director: Inder Kaul, M.D., MPH Asahi Kasei Pharma America Corporation
  More Information

Additional Information:
No publications provided

Responsible Party: Asahi Kasei Pharma America Corporation
ClinicalTrials.gov Identifier: NCT01598831     History of Changes
Other Study ID Numbers: 3-001
Study First Received: May 11, 2012
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Asahi Kasei Pharma America Corporation:
sepsis

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Sepsis
Toxemia
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Infection
Inflammation
Pathologic Processes
Systemic Inflammatory Response Syndrome
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014