Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis

PHASE2/PHASE3SuspendedINTERVENTIONAL
Enrollment

1,280

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

January 31, 2014

Study Completion Date

December 31, 2014

Conditions
Severe Sepsis
Interventions
DRUG

Talactoferrin alfa

15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit

DRUG

Placebo

15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit

Trial Locations (100)

1050

Hôpitaux IRIS Sud, Brussels

1070

Hôpital Erasme, Brussels

1090

UZ Brussel, Brussels

1200

Cliniques Universitaires Saint-Luc, Brussels

1340

Clinique Saint-Pierre, Ottignies

3600

Ziekenhuis Oost-Limburg, Genk

4000

CHU de Liège, Liège

5530

Cliniques Universitaires UCL de Mont-Godinne, Yvoir

7000

Centre Hospitalier de Dinant, Mons

8208

Hospital de Sabadell, Sabadell

9000

UZ Gent, Ghent

13353

Charité - Universitätsmedizin Berlin, Berlin

15232

Cancer Institute, Hillman Cancer Center, Pittsburgh

16470

Centre Hospitalier Angouleme, Saint-Michel

19718

Christiana Care Health Services, Newark

20037

George Washington University Hospital, Washington D.C.

22100

Western Galilee Hospital - Nahariya, Nahariya

27401

Moses Cone Memorial Hospital, Greensboro

27517

Wake Forest University Health Sciences, Winston-Salem

28040

Hospital Clinico San Carlos, Madrid

28046

Hospital Universitario La Paz, Madrid

Hospital Universitario La Paz, Madrid

28905

Hospital Universitario de Getafe, Getafe

31096

Rambam Medical Center, Haifa

33756

Bay Area Chest Physicians, Clearwater

34362

The Lady Davis Carmel Medical Center, Haifa

35249

University of Alabama - Birmingham, Birmingham

36608

Providence Hospital, Mobile

37044

Hôpital Bretonneau, Tours

38163

University of Tennessee, Memphis

38700

Hôpital Albert Michallon / La Tronche, La Tronche

43007

Hospital Universitari de Tarragona Joan XXIII, Tarragona

43214

Riverside Methodist Hospital, Columbus

43608

St. Vincent Mercy Medical Center, Toledo

45067

Hôpital de la Source, Orléans

46202

Methodist Research Institute, Indianapolis

48202

Henry Ford Hospital, Detroit

49100

Rabin Medical Center, Petah Tikva

49933

Hôtel Dieu, Angers

52242

University of Iowa, Iowa City

53105

Universitätsklinikum Bonn, Bonn

53792

University of Wisconsin Medical School, Madison

60302

West Suburban Hospital Medical Center, Oak Park

60590

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

61603

Peoria Pulmonary Associates, Peoria

63141

St. Johns Mercy Medical Center, St Louis

66160

University of Kansas Medical Center, Kansas City

67063

Klinikum der Stadt Ludwigshafen gGmbH, Ludwigshafen

68198

University of Nebraska Medical Center, Omaha

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

73104

University of Oklahoma Health Science Center, Oklahoma City

75679

Hôpital Cochin, Paris

77030

Baylor College of Medicine, Houston

79905

Texas Tech Health Science Center, El Paso

80204

Denver Health Medical Center, Denver

81545

Klinikum Harlaching, München

82013

Centre Hospitalier de Montauban, Montauban

83404

Eastern Idaho Medical Consultants, Idaho Falls

84157

LDS Hospital, Murray

85008

Maricopa Medical Center, Maricopa

85925

Centre Hospitalier Départemental La Roche sur Yon, Luçon, Montaigu - Les Oudaries, La Roche-sur-Yon

86021

Hôpital de la Miletrie, Poitiers

87042

Hôpital Universitaire Dupuytren, Limoges

91031

Shaare Zedek Medical Center, Jerusalem

91120

Hadassah University Hospital Ein Kerem, Jerusalem

91342

UCLA Medical Center, Sylmar

92123

Sharp Memorial Hospital, San Diego

92868

St. Joseph Hospital, Orange

95107

Centre Hospitalier Victor Dupouy, Argenteuil

99089

Helios Klinikum Erfurt, Erfurt

94305-5117

Stanford University Hospital, Stanford

01199

Baystate Medical Center, Springfield

08103

Cooper University Hospital, Camden

02903

Rhode Island Hospital, Providence

V5Z 1M9

Vancouver General Hospital, Vancouver

V8R 1J8

Royal Jubilee Hospital, Victoria

R2H 2A6

St. Boniface General Hospital, Winnipeg

R3A 1R9

Health Sciences Centre, Winnipeg

R3J 3M7

Grace Hospital, Winnipeg

B3H 3A7

Queen Elizabeth II Health Sciences Center, Halifax

K7L 2V7

Kingston General Hospital, Kingston

N8X 3V6

Windsor Regional Hospital, Windsor

H3T 1C5

SMBD - Jewish General Hospital, Montreal

DK-9100

Aalborg Sygehus, Aalborg

DK-5000

Odense universitetshospital, Odense

07747

Klinikum der Friedrich-Schiller-Universität Jena, Jena

5223 GZ

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

1081 HV

VU Medisch Centrum, Amsterdam

7334 DZ

Gelre Ziekenhuizen, Apeldoorn

8934 AD

Medisch Centrum Leeuwarden, Leeuwarden

6525 GA

UMC St. Radboud, Nijmegen

3083 AN

Ikazia Ziekenhuis, Rotterdam

08003

Hospital del Mar, Barcelona

08907

Hospital Universitari De Bellvitge, L'Hospitalet de Llobregat

08221

Hospital Mutua de Terrassa, Terrassa

AB25 2ZN

Aberdeen Royal Infirmary, Aberdeen

LS9 7TF

St James's University Hospital, Leeds

EH54 6PP

St John's Hospital, Livingston

NW1 2BU

University College London, London

SE1 7EH

St. Thomas' Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Agennix

INDUSTRY

NCT01273779 - Safety and Efficacy of Talactoferrin Alfa in Patients With Severe Sepsis | Biotech Hunter | Biotech Hunter