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

PHASE3CompletedINTERVENTIONAL
Enrollment

816

Participants

Timeline

Start Date

October 29, 2012

Primary Completion Date

April 5, 2018

Study Completion Date

February 28, 2019

Conditions
Severe SepsisCoagulopathy
Interventions
DRUG

ART-123

Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days

DRUG

Placebo

Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.

Trial Locations (161)

1115

Szent Imre Hospital, Anesthesiology and Intensive Care Unit, Budapest

3021

Sunshine Hospital, Melbourne

3175

Dandenong Hospital Monash Health, Dandenong

5000

Royal Adelaide Hospital, Adelaide

6021

Wellington District Health Board, Newtown

10065

Memorial Sloan Kettering Cancer Center, New York

19104

Philadelphia

21000

CHU de Dijon, Hopital Bocage Central, Dijon

23079

Archet 1 University Hospital of Nice, Nice

27710

Durham

30342

Atlanta

33600

University Hospital of Bordeaux, Pessac

36608

Mobile

39216

Jackson

40202

Louisville

41701

Hazard

43215

Columbus

44093

Service de reanimation médicale. CHU Hotel Dieu, Nantes

46202

Indianapolis

48201

Detroit Receiving Hospital, Detroit

Harper Hospital - Wayne State University School of Medicine, Detroit

48235

Sinai-Grace Hospital, Detroit

54074

Universitätsklinikum der RWTH Aachen, Aachen

57701

Rapid City

59037

CHRU Lille-Pole Reanimation, Lille

59701

Butte

63110

Washington University in St. Louis, St Louis

67000

Nouvel hospital civil, Strasbourg

73104

Oklahoma City

75013

La Pitié Salpétrière, Paris, Paris

77030

2 of 2, Houston

83404

Idaho Falls

84107

Murray

85008

Phoenix

122001

Artemis Hospital, Gurgaon

194354

St George City Hospital, Saint Petersburg

354057

City Hospital #4, Sochi

380015

Shalby Hospital, Ahmedabad

411011

Ruby Hall Clinic, Pune

411013

Noble Hospital, Pune

Noble Hospital, Pune

411043

Bharati Vidyapeeth Deemed University Medical College Bharti Hospital and Research Centre, Pune

440010

Care Hospital, Nagpur

500018

St. Theresa Hospital, Hyderabad

560099

Mazumdar Shaw Medical Centre (Unit of Narayana Health), Bangalore

570004

JSS Hospital, Mysore

590010

KLES Dr. Prabhakar Kore Hospital & Medical Research Centre, Belagavi

650000

City Clinical Hospital #3 n.a. M.A. Pogorbunskiy, Kemerovo

660022

Krasnoyarsk Regional Clinocal Hospital, Krasnoyarsk

07631

Englewood

X5004BAL

Hospital Italiano de Cordoba, Córdoba

Unknown

Prince of Wales Hospital, Randwick

Royal Brisbane and Women's Hospital, Herston

Princess Alexandra Hospital, Woolloongabba

Bendigo Hospital, Bendigo

Monash Medical Centre, Clayton

Western Hospital, Footscray

Austin Health, Heidelberg

UZ Antwerpen, Antwerp

Cliniques Du Sud-Luxerbourg (CSL), Hospital Saint Joseph, Arlon

CHU Brugmann, Brussels

Hopital Erasme, Brussels

Hopitaux Iris Sud, Brussels

UCL St. Luc, Brussels

UZ Brussel, Brussels

Centre Hospitalier de Dinant, Dinant

UZ Gent, Ghent

Clinique Saint-Pierre, Ottignies

UCL Mont-Godinne, Yvoir

Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte

Fundaçao Faculdade Regional de Medicina Sao Jose do Rio Preto, São José do Rio Preto

"Anesthesiology and Intensive Care Clinic, University Multiprofile Hospital For Active Treatment Sveti Georgi, Plovdiv", Plovdiv

"Department of Anesthesiology and Intensive Care Multiprofile Hospital For Active Treatment Tokuda Hospital Sofia, Sofia", Sofia

Winnipeg

Halifax

Windsor

Montreal

Clinical Hospital Center Zagreb, Medical ICU, Zagreb

Clinical Hospital Dubrava, Department of Anesthesiology and resuscitation, Zagreb

University Hospital Center Zagreb, Department of Anesthesiology, Reanimatology and Intensive Care Medicine, Zagreb

University Hospital Brno, Department of Infectious Diseases, Brno

University Hospital Hradec Kralove, Department of Anaesthesiology, Resuscitation and Intensive Care, Hradec Králové

General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine, Prague

University Hospital Kralovske Vinohrady, Department of Anesthesiology and Resuscitation, Prague

Masaryk´s Hospital Ustni nad Labem, o.z., Department of Infectious Diseases, Ústí nad Labem

Helsingin Yliopistollinen Keskussairaala (HYKS) (Helsinki University Central Hospital (HUCH)), Helsinki

Keski-Suomen Keskussairaala (Central Finland Central Hospital), Jyväskylä

Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital), Kuopio

Tampereen Yliopistollinen Sairaala (Tampere University Hospital) (TAYS) - Keskussairaala (Central Hospital), Tampere

CHU D'Anger, Angers

CH-Hôpital Albert Michallon, Grenoble

Centre Hospitalier Départemental de Vendée-Les Oudairies, La Roche-sur-Yon

CHU Limoges, Limoges

Centre Hospitalier Universitaire Nîmes, Nîmes

Hôpital COCHIN, Paris

CH Lyon Sud, Pierre-Bénite

Hôpital Sainte Musse, Toulon

CHU Tours, Hopital Bretonneau, Tours

Helios Klinikum Erfurt, Erfurt

Klinikum der Johann-Wolfgang Goethe-Universität, Frankfurt am Main

Shalby, Ahmedabad

King Edward Memorial Hospital & Research Centre, Pune

Maulana Azad Medical College and Associated L N Hospital, New Delhi

Hi-tech Medical College & Hospital, Bhubaneswar

Barzilai Medical Center, Ashkelon

Rambam Medical Center, Haifa

The Lady Davis Carmel Medical Center, Haifa

Shaare Zedek Medical Center, Jerusalem

Rabin Medical Center, Petah Tikva

Kaplan Medical Center, Rehovot

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

VUMC, Amsterdam

Ziekenhuis Gelderse Vallei, Ede

Medisch Spectrum Twente, Enschede

University Medical Center Groningen, Groningen

Medisch Centrum Leeuwarden, Leeuwarden

UMC St. Radboud, Nijmegen

Ikazia Ziekenhuis, Rotterdam

Auckland District Health Board, Auckland

Christchurch Hospital, Christchurch

Hawkes Bay Regional Hospital Intensive Care Unit Omahu Road, Hastings

Hospital Nacional Almenara Yrigoyen - EsSALUD, Lima

Hospital Nacional FAP, Lima

Arkhangelsk Regional Clinical Hospital, Arkhangelsk

Volosevich City Clinical Hospital #1, Arkhangelsk

Kuban State Medical University (Site Facility: Krasnodar Regional Clinical Hospital #2), Krasnodar

Vishnevsky Institute of Surgery, Moscow

Aleksandrovskaya City Hospital, Saint Petersburg

City Hospital #40, Saint Petersburg

Mariinskaya City Hospital, Saint Petersburg

Mechnikov North-Western State Medical University n.a. I.I. Mechnikov, Saint Petersburg

Clinic for Infectious Diseases, Clinical Center Nis, Niš

Korea University Anam Hospital, Seongdu

Asan Medical Center, Seoul

Samsung Medical Center [Pulmonology], Seoul

Seoul National University Hospital, Seoul

Complexo Hospitalario Universitario A Coruña, A Coruña

Hospital Universitario Mutua Terrassa Intensive Care, Barcelona

Servicio de Medicina Intensiva Hospital Universitario Valle de Hebron, Barcelona

Hospital Clínico San Carlos, Madrid

Hospital de Sabadell, Sabadell

Hospital Universitari de Tarragona Joan XXIII, Tarragona

Chi Mei Medical Center Yong Kang, Yongkang District

Taichung Veterans General Hospital [Pulmonology], Taichung

National Taiwan University Hospital, Taipei

Royal Liverpool University Hospital, Liverpool

Manchester Royal Infirmary, Manchester

Derriford Hospital, Plymouth

95010-005

Hospital Pompéia, Brasil

T1Y 6J4

2 of 2, Calgary

T2V 1PA

Calgary

T3M 1M4

Calgary

V5Z 1M9

Vancouver

V6Z 1Y6

2 of 2, Vancouver

V8R-1J8

1 of 2, Victoria

V8R1J8

Victoria

N6A5W9

London

KIH 8L6

1 of 2, Ottawa

2 of 2, Ottawa

B9 5SS

Birmingham Heartlands Hospital, Birmingham

HU3 2JZ

Hull Royal Infirmary, Hull

All Listed Sponsors
lead

Asahi Kasei Pharma America Corporation

INDUSTRY

NCT01598831 - Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy | Biotech Hunter | Biotech Hunter