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

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.
ClinicalTrials.gov Identifier: NCT01598831
Recruitment Status : Recruiting
First Posted : May 15, 2012
Last Update Posted : January 5, 2018
Information provided by (Responsible Party):
Asahi Kasei Pharma America Corporation

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

Condition or disease Intervention/treatment Phase
Severe Sepsis Coagulopathy Drug: ART-123 Drug: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : August 2012
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Primary Efficacy Outcome Measure [ Time Frame: 28 days ]
    28 day all-cause mortality

  2. Primary Safety Outcome Measure [ Time Frame: Through Study Day 28 ]
    Adverse Events

  3. 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.)

  4. Primary Safety Outcome Measure [ Time Frame: Through Study Day 28 ]
    Serious Adverse Events

Secondary Outcome Measures :
  1. Secondary Efficacy Outcome Measure [ Time Frame: 3 months ]
    Follow up all-cause mortality at 3 months

  2. 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.

  3. Secondary Safety Outcome Measure [ Time Frame: 18 months ]
    Presence of Anti-drug antibodies up to 18 months

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598831

Contact: Scott Oshana 781-419-5039 info@akpamerica.com

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
Mobile, Alabama, United States, 36608
United States, Arizona
Phoenix, Arizona, United States, 85008
Tucson, Arizona, United States, 85724
United States, California
Colton, California, United States, 92324
Los Angeles, California, United States, 90033
Sacramento, California, United States, 95817
San Diego, California, United States, 92123
Stanford University Recruiting
Stanford, California, United States, 94305
United States, Delaware
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Florida
Clearwater, Florida, United States, 33756
Miami, Florida, United States, 33125
Orlando, Florida, United States, 32804
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30342
Augusta, Georgia, United States, 30909
United States, Idaho
Idaho Falls, Idaho, United States, 83404
United States, Illinois
2 of 2 Withdrawn
Chicago, Illinois, United States, 60611
1 of 2 Withdrawn
Chicago, Illinois, United States, 60612
Maywood, Illinois, United States, 60153
Oak Park, Illinois, United States, 60302
Peoria, Illinois, United States, 61637
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas City, Kansas, United States, 66160-7381
Topeka, Kansas, United States, 66604
United States, Kentucky
Hazard, Kentucky, United States, 41701
Louisville, Kentucky, United States, 40202
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02115
Springfield, Massachusetts, United States, 01199
Worcester, Massachusetts, United States, 01655
United States, Michigan
Detroit Receiving Hospital Recruiting
Detroit, Michigan, United States, 48201
Harper Hospital - Wayne State University School of Medicine Recruiting
Detroit, Michigan, United States, 48201
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Sinai-Grace Hospital Recruiting
Detroit, Michigan, United States, 48235
United States, Minnesota
Saint Paul, Minnesota, United States, 55101
United States, Mississippi
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Saint Louis, Missouri, United States, 63110
United States, Montana
Butte, Montana, United States, 59701
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, New Jersey
Camden, New Jersey, United States, 08103
Englewood, New Jersey, United States, 07631
Hackensack, New Jersey, United States, 07601
United States, New York
Buffalo, New York, United States, 14215
Mineola, New York, United States, 11501
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Asheville, North Carolina, United States, 28805
Chapel Hill, North Carolina, United States, 27599
Durham, North Carolina, United States, 27710
Greensboro, North Carolina, United States, 27403
Greenville, North Carolina, United States, 27834
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43215
Toledo, Ohio, United States, 43608
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73104
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Portland, Oregon, United States, 97239
Not yet recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Nashville, Tennessee, United States, 37232-2560
United States, Texas
Austin, Texas, United States, 78752
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
1 of 2 Withdrawn
Houston, Texas, United States, 77030
2 of 2 Recruiting
Houston, Texas, United States, 77030
United States, Utah
Murray, Utah, United States, 84107
United States, Virginia
Falls Church, Virginia, United States, 22042
United States, Washington
Everett, Washington, United States, 98206
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Instituto Medico Platense Withdrawn
La Plata, Buenos Aires, Argentina, B1900AVG
Nuestra Señora de la Misericordia Withdrawn
Cordoba, Argentina, X5000JRD
Hospital Italiano de Cordoba Terminated
Cordoba, Argentina, X5004BAL
Sanatorio del Salvador Withdrawn
Cordoba, Argentina, X5004BCL
Hospital Privado Centro Médico de Cordoba Withdrawn
Cordoba, Argentina
Nuevo Hospital San Roque Withdrawn
Cordoba, Argentina
Australia, Australian Capital Territory
Calvary Health Care ACT Withdrawn
Bruce, Australian Capital Territory, Australia
Australia, New South Wales
Prince of Wales Hospital Terminated
Randwick, New South Wales, Australia
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Herston, Queensland, Australia
Nambour, Queensland, Australia
Gold Coast Hospital Withdrawn
Southport, Queensland, Australia
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Bendigo Hospital Terminated
Bendigo, Victoria, Australia
Monash Medical Centre Recruiting
Clayton, Victoria, Australia
Dandenong Hospital Monash Health Recruiting
Dandenong, Victoria, Australia, 3175
Western Hospital Recruiting
Footscray, Victoria, Australia
Austin Health Recruiting
Heidelberg, Victoria, Australia
Sunshine Hospital Recruiting
Melbourne, Victoria, Australia, 3021
Epworth Health Care Withdrawn
Richmond, Victoria, Australia
Australia, Western Australia
Fremantle Hospital Withdrawn
Fremantle, Western Australia, Australia
UZ Antwerpen Recruiting
Antwerpen, Belgium
Cliniques Du Sud-Luxerbourg (CSL), Hospital Saint Joseph Recruiting
Arlon, Belgium
CHU Brugmann Terminated
Brussels, Belgium
Hopital Erasme Recruiting
Brussels, Belgium
Hopitaux Iris Sud Terminated
Brussels, Belgium
UCL St. Luc Recruiting
Brussels, Belgium
UZ Brussel Terminated
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
Santa Casa de Misericordia de Belo Horizonte Recruiting
Belo Horizonte, MG, Brazil
Santa Casa de Misericordia de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90020-090
Hospital São Lucas da PUCRS Recruiting
Porto Alegre, RS, Brazil, 90610
Fundaçao Faculdade Regional de Medicina Sao Jose do Rio Preto Recruiting
Sao Jose do Rio Preto, SP, Brazil
Hospital Samaritano Recruiting
São Paulo, SP, Brazil, 01232-010
Hospital Alemão Oswaldo Cruz Withdrawn
São Paulo, SP, Brazil
Hospital São Paulo - Associação Paulista para o Desenvolvimento da Medicina Withdrawn
São Paulo, SP, Brazil
Hospital Israelita Albert Einstein Withdrawn
Morumbi, São Paulo, Brazil, 05651-901
Hospital Pompéia Recruiting
Brasil, Brazil, 95010-005
Hospital Ernesto Dornelles - Centro de Pesquisa Clínica Withdrawn
Porto Alegre, Brazil, 90160-093
Assoc. Portuguesa de Beneficiência Hospital Sao Joaquim Withdrawn
São Paulo, Brazil, 01323-001
Anesthesiology and Intensive Care Clinic, University Multiprofile Hospital For Active Treatment "Sveti Georgi", Plovdiv Terminated
Plovdiv, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia Withdrawn
Sofia, Bulgaria, 1606
Department of Anesthesiology and Intensive Care Multiprofile Hospital For Active Treatment "Tokuda Hospital Sofia", Sofia Terminated
Sofia, Bulgaria
Anesthesiology and Intensive Care Clinic Withdrawn
Varna, Bulgaria, 9010
Canada, Alberta
2 of 2 Recruiting
Calgary, Alberta, Canada, T1Y 6J4
Calgary, Alberta, Canada, T2V 1PA
Calgary, Alberta, Canada, T3M 1M4
1 of 2 Recruiting
Calgary, Alberta, Canada, T5H3V9
Edmonton, Alberta, Canada, T5H3V9
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
2 of 2 Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
1 of 2 Recruiting
Victoria, British Columbia, Canada, V8R-1J8
Victoria, British Columbia, Canada, V8R1J8
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Winnipeg, Manitoba, Canada, R3J-3M7
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
London, Ontario, Canada, N6A5W9
1 of 2 Recruiting
Ottawa, Ontario, Canada, KIH 8L6
2 of 2 Recruiting
Ottawa, Ontario, Canada, KIH 8L6
North York General Hospital Recruiting
Toronto, Ontario, Canada, M2K 1E1
Mount Sinai Hospital Recruiting
Toronto, Ontario, Canada, M5G 1X5
Windsor, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Quebec, Canada, G1V 4G5
Hospital Pablo Tobon Uribe Withdrawn
Medellin, Antioquia, Colombia
Oncomedica S.A. Withdrawn
Monteria, Cordoba, Colombia
Fundacion Cardiovascular de Colombia Withdrawn
Bucaramanga, Santander, Colombia
University Hospital for Infectious Diseases, Institute for Infectious medicine and neuroinfectology Withdrawn
Zagreb, Croatia, 10000
Clinical Hospital Center Zagreb, Medical ICU Terminated
Zagreb, Croatia
Clinical Hospital Dubrava, Department of Anesthesiology and resuscitation Terminated
Zagreb, Croatia
University Hospital Center Zagreb, Department of Anesthesiology, Reanimatology and Intensive Care Medicine Terminated
Zagreb, Croatia
University Hospital Brno, Department of Anaesthesiology, Resuscitation and Intensive Medicine Recruiting
Brno, Czech Rep, Czechia, 62500
University Hospital Motol Recruiting
Praha, Czech Rep, Czechia, 15006
University Hospital Brno, Department of Infectious Diseases Terminated
Brno, Czechia
University Hospital Hradec Kralove, Department of Anaesthesiology, Resuscitation and Intensive Care Terminated
Hradec Kralove, Czechia
Regional Hospital Kolin, a.s., Department of Anaesthesilogy and Resuscitation Withdrawn
Kolin, Czechia, 28002
University Hospital Ostravam, Department of Anaesthesiology, Resuscitation and Intensive Medicine Withdrawn
Ostrava - Poruba, Czechia, 708 52
University Hospital Kralovske Vinohrady, Department of Anesthesiology and Resuscitation Recruiting
Prague 10, Czechia
General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine Recruiting
Prague 2, Czechia
University Hospital Motol, Department of Anaesthesiology and Resuscitation CHU 2nd FM and UH Motol Withdrawn
Prague, Czechia, 15006
Masaryk´s Hospital Ustni nad Labem, o.z., Department of Infectious Diseases Terminated
Usti nad Labem, Czechia
Regional Hospital T. Bati, PLC Withdrawn
Zlin, Czechia, 762 75
Helsingin Yliopistollinen Keskussairaala (HYKS) (Helsinki University Central Hospital (HUCH)) Recruiting
Helsinki, Finland
Keski-Suomen Keskussairaala (Central Finland Central Hospital) Terminated
Jyväskylä, Finland
Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital) Recruiting
Kuopio, Finland
Etela-Pohjanmaan Sairaanhoitopiiri - Seinajoen Keskussairaala (Seinajoki Central Hospital) Withdrawn
Seinajoki, Finland
Tampereen Yliopistollinen Sairaala (Tampere University Hospital) (TAYS) - Keskussairaala (Central Hospital) Recruiting
Tampere, Finland
Turku University Hospital Recruiting
Turku, Finland, 20520
Archet 1 University Hospital of Nice Recruiting
Nice, Cedex 3, France, 23079
Service de reanimation médicale. CHU Hotel Dieu Recruiting
Nantes, Nantes Cedex 01, France, 44093
CHU D'Anger Recruiting
Angers Cedex 9, France
CHU de Dijon, Hopital Bocage Central Terminated
Dijon, France, 21000
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 Withdrawn
Le Kremlin-Bicêtre, France
CHRU Lille-Pole Reanimation Recruiting
Lille, France, 59037
CHU Limoges Recruiting
Limoges cedex, France
Hospices Civils de Lyon - Hopital de la Croix-Rousse Recruiting
Lyon, France, 69004
Centre Hospitalier Universitaire Nîmes Recruiting
Nîmes Cedex 9, France
CHR Orléans, Hopital La Source Withdrawn
Orléans, France
La Pitié Salpétrière, Paris Terminated
Paris, France, 75013
Hôpital COCHIN Recruiting
Paris, France
Reanimation Hôpital Saint Antoine Recruiting
Paris, France
University Hospital of Bordeaux Recruiting
Pessac, France, 33600
CH Lyon Sud Terminated
Pierre-Bénite cedex, France
Centre Hospitalier Universitaire de Poitiers Withdrawn
Poitiers cedex, France, 86021
CH Angouleme, Saint Michel Withdrawn
Saint Michel, France
Nouvel hospital civil Recruiting
Strasbourg, France, 67000
Hôpital Sainte Musse Recruiting
Toulon, France
Hôpital Rangueil Withdrawn
Toulouse, France
CHU Tours, Hopital Bretonneau Recruiting
Tours, France
Hôpital de Brabois Rue de Morvan Recruiting
Vandoeuvre-les-Nancy, France
Universitätsklinikum der RWTH Aachen Recruiting
Aachen, Germany, 54074
Vivantes Klinikum Neukölln Recruiting
Berlin, Germany, 12351
Charitè Campus Mitte Withdrawn
Berlin, Germany
Charité - Universitätsmedizin Berlin Withdrawn
Berlin, Germany
Helios Klinikum Erfurt Terminated
Erfurt, Germany
Klinikum der Johann-Wolfgang Goethe-Universität Recruiting
Frankfurt am Main, Germany
Universitätsklinikum Jena Withdrawn
Jena, Germany
Universitätsklinikum Leipzig AöR Recruiting
Leipzig, Germany
Klinikum Harlaching Withdrawn
München, Germany
Evangelisches Krankenhaus Witten Withdrawn
Witten, Germany, 58455
ATTIKO University Hospital Withdrawn
Chaidari, Athens, Greece
General Hospital of Athens "EVANGELISMOS" Withdrawn
Athens, Greece
General Hospital of Chest Diseases "Sotiria" Withdrawn
Athens, Greece
University Hospital of Ioannina Withdrawn
Ioannina, Greece
General Hospital of Larissa ''Koutlimpanio & Triantafyllio'' Withdrawn
Larissa, Greece
Agioi Anargyroi Anticancer Hospital Withdrawn
Néa Kifisiá, Greece
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
Maulana Azad Medical College and Associated L N Hospital Recruiting
New Delhi, Delhi, India
Shalby Hospital Recruiting
Ahmedabad,, Gujarat, India, 380015
Shalby Recruiting
Ahmedabad, Gujarat, India
Artemis Hospital Recruiting
Gurgaon, Haryana, India, 122001
SUT Hospital Withdrawn
Trivandrum, Kerala, India, 695004
Ruby Hall Clinic Recruiting
Pune, Maharashtra, India, 411011
Noble Hospital Recruiting
Pune, Maharashtra, India, 411013
Deenanath Mangeshkar Hospital and Research Centre Withdrawn
Pune, Maharashtra, India
King Edward Memorial Hospital & Research Centre Terminated
Pune, Maharashtra, India
Hi-tech Medical College & Hospital Terminated
Bhubaneswar, Odisha, India
Bharati Vidyapeeth Deemed University Medical College Bharti Hospital and Research Centre Recruiting
Pune, Pune, Maharashtra, India, 411043
Global Health City Withdrawn
Chennai, Tamil Nadu, India, 600100
Meenakshi Mission Hospital and Research Centre Withdrawn
Madurai, Tamilnadu, India
St. Theresa Hospital Recruiting
Hyderabad, Telangana State, India, 500018
Intensive Care Unit, Columbia Asia Referral Hospital-Yeshwanthpur Withdrawn
Bangalore, India, 560055
Mazumdar Shaw Medical Centre (Unit of Narayana Health) Recruiting
Bangalore, India, 560099
KLES Dr. Prabhakar Kore Hospital & Medical Research Centre Recruiting
Belgaum, India, 590010
Vintage Hospital & Medical Research Centre Withdrawn
Goa, India, 403001
JSS Hospital Recruiting
Mysore, India, 570004
Care Hospital Terminated
Nagpur, India, 440010
Noble Hospital Recruiting
Pune, India, 411013
Barzilai Medical Center Terminated
Ashkelon, Israel
Hillel Yaffe Medical Center Withdrawn
Hadera, Israel, 38100
Rambam Medical Center Terminated
Haifa, Israel
The Lady Davis Carmel Medical Center Recruiting
Haifa, Israel
Wolfson Medical Center Withdrawn
Holon, Israel
Hadassah Ein Karen Medical Center Withdrawn
Jerusalem, Israel
Shaare Zedek Medical Center Terminated
Jerusalem, Israel
Rabin Medical Center Recruiting
Petach Tikva, Israel
Kaplan Medical Center Recruiting
Rehovot, Israel
Korea, Republic of
Busan Paik Hospital Recruiting
Busan, Korea, Republic of
Gachon University Gil Medical Center [Infectious Disease] Recruiting
Incheon, Korea, Republic of
Korea University Anam Hospital Recruiting
Seongdu, Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Samsung Medical Center [Pulmonology] Recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Yonsei University Medical Center Recruiting
Soeul, Korea, Republic of
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
Canisius-Wilhelmina Ziekenhuis Recruiting
Nijmegen, Netherlands, 6532 SZ
UMC St. Radboud Recruiting
Nijmegen, Netherlands
Ikazia Ziekenhuis Recruiting
Rotterdam, Netherlands
New Zealand
Auckland District Health Board Recruiting
Auckland, New Zealand
Christchurch Hospital Terminated
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 Withdrawn
Waitakere, New Zealand
Hospital Nacional Almenara Yrigoyen - EsSALUD Terminated
Lima, Lima Province, Peru
Hospital Nacional Arzobispo Loayza Withdrawn
Lima, Lima Province, Peru
Hospital Nacional Edgardo Rebagliati Martins Withdrawn
Lima, Lima Province, Peru
Hospital Nacional FAP Terminated
Lima, Lima Province, Peru
Russian Federation
Arkhangelsk Regional Clinical Hospital Recruiting
Arkhangelsk, Russian Federation
Volosevich City Clinical Hospital #1 Recruiting
Arkhangelsk, Russian Federation
City Clinical Hospital #3 n.a. M.A. Pogorbunskiy Recruiting
Kemerovo, Russian Federation, 650000
Kuban State Medical University (Site Facility: Krasnodar Regional Clinical Hospital #2) Recruiting
Krasnodar, Russian Federation
Krasnoyarsk Regional Clinocal Hospital Recruiting
Krasnoyarsk, Russian Federation, 660022
I.M. Sechenov Moscow State Budgetary Medical University Recruiting
Moscow, Russian Federation
Vishnevsky Institute of Surgery Terminated
Moscow, Russian Federation
City Clinical Hospital #1 Recruiting
Novosibirsk, Russian Federation
St George City Hospital Recruiting
Saint Petersburg, Russian Federation, 194354
City Hospital #14 Withdrawn
Saint Petersburg, Russian Federation
City Hospital #40 Recruiting
Saint Petersburg, Russian Federation
St. Petersburg Janelidze Emergency Research Institute Recruiting
Saint Petersburg, Russian Federation
City Hospital #4 Recruiting
Sochi, Russian Federation, 354057
Aleksandrovskaya City Hospital Recruiting
St. Petersburg, Russian Federation
Mariinskaya City Hospital Recruiting
St. Petersburg, Russian Federation
Mechnikov North-Western State Medical University n.a. I.I. Mechnikov Recruiting
St. Petersburg, Russian Federation
Clinical Centre Serbia, Clinic of Neurology, Emergency Neurology Withdrawn
Belgrade, Serbia, 11000
Clinical Centre Serbia,Center for Anestesiology and Reanimatology Withdrawn
Belgrade, Serbia
Clinical Center Kragujevac, Center for Anesthesia and Reanimation Withdrawn
Kragujevac, Serbia
Clinic for Infectious Diseases, Clinical Center Nis Terminated
Nis, Serbia
Complexo Hospitalario Universitario A Coruña Recruiting
A Coruña, Spain
H. Universitario Príncipe de Asturias Withdrawn
Alcalá de Henares, Spain
Hospital Clinic de Barcelona Withdrawn
Barcelona, Spain, 08036
Hospital Universitari De Bellvitge Withdrawn
Barcelona, Spain
Hospital Universitario Mutua Terrassa Intensive Care Recruiting
Barcelona, Spain
Servicio de Medicina Intensiva Hospital Universitario Valle de Hebron Recruiting
Barcelona, Spain
Hospital de Gran Canaria Dr. Negrin Withdrawn
Las Palmas de Gran Canaria, Spain
Clinica Moncloa Withdrawn
Madrid, Spain, 28008
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Hospital de Sabadell Recruiting
Sabadell, Spain
Complejo Hospitalario Nuestra Señora de Valme Withdrawn
Sevilla, Spain
Hospital Universitari de Tarragona Joan XXIII Recruiting
Tarragona, Spain
Hospital de Txagorritxu Withdrawn
Vitoria, Spain
Chi Mei Medical Center Yong Kang Recruiting
Yongkang, Tainan, Taiwan
Taichung Veterans General Hospital [Pulmonology] Recruiting
Taichung, Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Lin Kou Chang Gung Memorial Hospital Withdrawn
Taoyuan, Taiwan
Ankara University Medical Faculty Ibn-I Sina Hospital Withdrawn
Ankara, Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Withdrawn
Edirne, Turkey
Istanbul University Cerrhapasa Medical Faculty Withdrawn
Istanbul, Turkey
Istanbul University Istanbul Medical Faculty Withdrawn
Istanbul, Turkey
Dokuz Eylul University Medical Faculty Withdrawn
İzmir, Turkey
United Kingdom
Heart of England NHS Trust (Good Hope Hospital) Recruiting
Birmingham, United Kingdom, B75 7RR
Birmingham Heartlands Hospital Recruiting
Birmingham, United Kingdom, B9 5SS
University Hospital of Wales Recruiting
Cardiff, United Kingdom, CF14 4XW
James Paget University Hospital NHS Foundation Trust Withdrawn
Great Yarmouth, United Kingdom
Hull Royal Infirmary HICU 1 Recruiting
Hull, United Kingdom, HU3 2JZ
Hull Royal Infirmary Recruiting
Hull, United Kingdom, HU3 2JZ
St. James's University Hospital Withdrawn
Leeds, United Kingdom
Leicester Royal Infirmary Withdrawn
Leicester, United Kingdom
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom
St Thomas' Hospital Withdrawn
London, United Kingdom, SE1 7EH
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust Recruiting
Norwich, United Kingdom, NR4 7UY
Derriford Hospital Recruiting
Plymouth, United Kingdom
Musgrove Park Hospital Withdrawn
Taunton, United Kingdom
Sponsors and Collaborators
Asahi Kasei Pharma America Corporation
Study Director: David Fineberg, M.D. Asahi Kasei Pharma America Corporation

Additional Information:
Responsible Party: Asahi Kasei Pharma America Corporation
ClinicalTrials.gov Identifier: NCT01598831     History of Changes
Other Study ID Numbers: 3-001
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018

Keywords provided by Asahi Kasei Pharma America Corporation:

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