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 July 2016 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: July 14, 2016
Last verified: July 2016
  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 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 ] [ 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: September 2018
Estimated Primary Completion Date: September 2017 (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   (Adult, Senior)
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 (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
  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: Scott Oshana 781-419-5039 info@akpamerica.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
Recruiting
Mobile, Alabama, United States
United States, Arizona
Terminated
Phoenix, Arizona, United States
United States, California
Withdrawn
Colton, California, United States
Recruiting
Los Angeles, California, United States
Withdrawn
Sacramento, California, United States
Withdrawn
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, Georgia
Recruiting
Augusta, Georgia, United States
Recruiting
Canton, Georgia, United States, 30114
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
Withdrawn
Peoria, Illinois, United States
United States, Indiana
Recruiting
Indianapolis, Indiana, 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
Withdrawn
Baltimore, Maryland, United States
United States, Massachusetts
Withdrawn
Springfield, Massachusetts, United States, 01199
Withdrawn
Worcester, Massachusetts, United States, 01655
United States, Minnesota
Recruiting
St. Paul, Minnesota, United States, 55101
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
Withdrawn
Omaha, Nebraska, United States
United States, New Jersey
Withdrawn
Camden, New Jersey, United States
Recruiting
Englewood, New Jersey, United States
United States, New York
Recruiting
Buffalo, New York, United States
Withdrawn
Mineola, New York, United States
United States, North Carolina
Withdrawn
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
Withdrawn
Greenville, North Carolina, United States
Withdrawn
Winston-Salem, North Carolina, United States
United States, Ohio
Withdrawn
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
Terminated
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
Nuevo Hospital San Roque Withdrawn
Cordoba, Argentina
Nuestra Señora de la Misericordia Withdrawn
Cordoba, Argentina, X5000JRD
Hospital Italiano de Cordoba Terminated
Cordoba, Argentina, X5004BAL
Hospital Privado Centro Médico de Cordoba Withdrawn
Cordoba, Argentina
Sanatorio del Salvador Withdrawn
Cordoba, Argentina, X5004BCL
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
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 Withdrawn
Richmond, Victoria, Australia
Australia, Western Australia
Fremantle Hospital Withdrawn
Fremantle, Western Australia, Australia
Belgium
UZ Antwerpen Recruiting
Antwerpen, Belgium
Cliniques Du Sud-Luxerbourg (CSL), Hospital Saint Joseph Recruiting
Arlon, Belgium
UZ Brussel Recruiting
Brussels, Belgium
Hopital Erasme Recruiting
Brussels, Belgium
Hopitaux Iris Sud Terminated
Brussels, Belgium
UCL St. Luc 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 Withdrawn
São Paulo, SP, Brazil
Hospital São Paulo - Associação Paulista para o Desenvolvimento da Medicina Withdrawn
São Paulo, SP, Brazil
Hospital Pompéia Recruiting
Brasil, Brazil, 95010-005
Hospital Ernesto Dornelles - Centro de Pesquisa Clínica Recruiting
Porto Alegre, Brazil, 90160-093
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 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
1 of 2 Recruiting
Calgary, Alberta, Canada, T2N 2T9
2 of 2 Recruiting
Calgary, Alberta, Canada, T1Y 6J4
Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Terminated
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
Recruiting
Victoria, British Columbia, Canada
Canada, Manitoba
Withdrawn
Winnipeg, Manitoba, Canada, R3A 1R9
Withdrawn
Winnipeg, Manitoba, Canada, R3J-3M7
Recruiting
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
Recruiting
London, Ontario, Canada
1 of 2 Recruiting
Ottawa, Ontario, Canada, KIH 8L6
2 of 2 Recruiting
Ottawa, Ontario, Canada, KIH 8L6
Terminated
Windsor, Ontario, Canada
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Colombia
Hospital Pablo Tobon Uribe Withdrawn
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
University Hospital Center Zagreb, Department of Anesthesiology, Reanimatology and Intensive Care Medicine 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 Terminated
Hradec Kralove, Czech Republic
Regional Hospital Kolin, a.s., Department of Anaesthesilogy and Resuscitation Withdrawn
Kolin, Czech Republic, 28002
University Hospital Ostravam, Department of Anaesthesiology, Resuscitation and Intensive Medicine Recruiting
Ostrava - Poruba, Czech Republic, 708 52
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 Terminated
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) Terminated
Jyvaeskylae, 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
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 Withdrawn
Le Kremlin-Bicêtre, France
CHU Limoges Recruiting
Limoges cedex, France
Centre Hospitalier Universitaire Nîmes Recruiting
Nîmes Cedex 9, France
CHR Orléans, Hopital La Source Withdrawn
Orléans, France
Hôpital COCHIN Recruiting
Paris, France
La Pitié Salpétrière, Paris Recruiting
Paris, France
Reanimation Hôpital Saint Antoine Recruiting
Paris, France
University Hospital of Bordeaux Recruiting
Pessac, France, 33600
CH Lyon Sud Recruiting
Pierre-Bénite cedex, France
Centre Hospitalier Universitaire de Poitiers Recruiting
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
Germany
Universitätsklinikum der RWTH Aachen Recruiting
Aachen, Germany, 54074
Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany
Vivantes Klinikum Neukölln Recruiting
Berlin, Germany, 12351
Charitè Campus Mitte 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
Universitätsklinikum Leipzig AöR Recruiting
Leipzig, Germany
Klinikum Harlaching Withdrawn
München, Germany
Evangelisches Krankenhaus Witten Withdrawn
Witten, Germany, 58455
Greece
ATTIKO University Hospital Recruiting
Chaidari, Athens, Greece
General Hospital of Athens "EVANGELISMOS" Recruiting
Athens, Greece
General Hospital of Chest Diseases "Sotiria" Recruiting
Athens, Greece
University Hospital of Ioannina Recruiting
Ioannina, Greece
General Hospital of Larissa ''Koutlimpanio & Triantafyllio'' Recruiting
Larissa, Greece
Agioi Anargyroi Anticancer Hospital Recruiting
Nea Kifissia, Greece
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
Shalby Recruiting
Ahmedabad, Gujarat, India
SUT Hospital Withdrawn
Trivandrum, Kerala, India, 695004
King Edward Memorial Hospital & Research Centre Terminated
Pune, Maharashtra, India
Deenanath Mangeshkar Hospital and Research Centre Withdrawn
Pune, Maharashtra, India
Hi-tech Medical College & Hospital Recruiting
Bhubaneswar, Odisha, India
Bharati Vidyapeeth Deemed University Medical College Bharti Hospital and Research Centre Recruiting
Katraj, Pune, India
Meenakshi Mission Hospital and Research Centre Withdrawn
Madurai, Tamilnadu, India
Intensive Care Unit, Columbia Asia Referral Hospital-Yeshwanthpur Withdrawn
Bangalore, India, 560055
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 Recruiting
Nagpur, India, 440010
Israel
Barzilai Medical Center Recruiting
Ashkelon, Israel
Hillel Yaffe Medical Center Withdrawn
Hadera, Israel, 38100
The Lady Davis Carmel Medical Center Recruiting
Haifa, Israel
Rambam Medical Center Terminated
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
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 Withdrawn
Waikato, New Zealand
Peru
Hospital Nacional Almenara Yrigoyen - EsSALUD Recruiting
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 Recruiting
Lima, Lima Province, Peru
Russian Federation
Arkhangelsk Regional Clinical Hospital Recruiting
Arkhangelsk, Russian Federation
Volosevich City Clinical Hospital #1 Recruiting
Arkhangelsk, Russian Federation
Kuban State Medical University (Site Facility: Krasnodar Regional Clinical Hospital #2) Recruiting
Krasnodar, Russian Federation
I.M. Sechenov Moscow State Budgetary Medical University Recruiting
Moscow, Russian Federation
Vishnevsky Institute of Surgery Recruiting
Moscow, Russian Federation
City Clinical Hospital #1 Recruiting
Novosibirsk, Russian Federation
St. Petersburg Janelidze Emergency Research Institute Recruiting
Saint Petersburg, Russian Federation
City Hospital #40 Recruiting
Saint Petersburg, Russian Federation
City Hospital #14 Recruiting
Saint Petersburg, Russian Federation
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
Serbia
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
Spain
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 Recruiting
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 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 Withdrawn
Sevilla, Spain
Hospital Universitari de Tarragona Joan XXIII Recruiting
Tarragona, Spain
Hospital de Txagorritxu Withdrawn
Vitoria, Spain
Taiwan
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 Recruiting
Taoyuan, Taiwan
Turkey
Ankara University Medical Faculty Ibn-I Sina Hospital Recruiting
Ankara, Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi Recruiting
Edirne, Turkey
Istanbul University Cerrhapasa Medical Faculty Recruiting
Istanbul, Turkey
Istanbul University Istanbul Medical Faculty Recruiting
Istanbul, Turkey
Dokuz Eylul University Medical Faculty Recruiting
İzmir, Turkey
United Kingdom
James Paget University Hospital NHS Foundation Trust Withdrawn
Great Yarmouth, United Kingdom
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 Recruiting
London, United Kingdom, SE1 7EH
Manchester Royal Infirmary Recruiting
Manchester, United Kingdom
Derriford Hospital Recruiting
Plymouth, United Kingdom
Musgrove Park Hospital Withdrawn
Taunton, United Kingdom
Sponsors and Collaborators
Asahi Kasei Pharma America Corporation
Investigators
Study Director: David Fineberg, M.D. Asahi Kasei Pharma America Corporation
  More Information

Additional Information:
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: July 14, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Asahi Kasei Pharma America Corporation:
sepsis

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

ClinicalTrials.gov processed this record on July 26, 2016