Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis

PHASE2CompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

August 31, 2009

Study Completion Date

February 28, 2010

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

Placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit

Trial Locations (34)

15213

University of Pittsburgh Medical Center Presbyterian Hospital, Pittsburgh

16470

Centre Hospitalier Angouleme, Saint-Michel

20037

The George Washington University Hospital, Washington D.C.

27157

Wake Forest University Baptist Medical Center, Winston-Salem

27517

Wake Forest University Health Sciences, Winston-Salem

27710

Duke University Medical Center, Durham

47105

Floyd Memorial Hospital and Health Services, New Albany

48202

Henry Ford Health System, Detroit

52242

University of Iowa Hospitals and Clinic, Iowa City

60302

West Suburban Medical Center, Oak Park

60612

Rush University Medical Center, Chicago

63110

St. Louis University, St Louis

63141

St. John's Mercy Medical Center, St Louis

66160

University of Kansas Medical Center, Kansas City

73104

University of Oklahoma Health Science Center, Oklahoma City

76508

Scott & White Memorial Hospital, Temple

77030

Ben Taub General Hospital, Houston

The Methodist Hospital, Houston

The University of Texas MD Anderson Cancer Center, Houston

79905

Texas Tech University Health Sciences Center, El Paso

80204

Denver Health Medical Center, Denver

82013

Centre Hospitalier de Montauban, Montauban

84143

Intermountain Medical Center, Salt Lake City

91342

Olive View- UCLA Medical Center, Sylmar

92354

Loma Linda University Medical Center, Loma Linda

95817

UC Davis Medical Center, Sacramento

99089

Helios Klinikum Erfurt, Erfurt

01199

Baystate Medical Center, Springfield

08103

Cooper University Hospital, Camden

02903

Rhode Island Hospital, Providence

V5Z 1M9

Vancouver General Hospital, Vancouver

K7L 2V7

Kingston General Hospital, Kingston

08208

Hospital de Sabadell, Sabadell

08221

Hospital Mutua de Terrassa, Terrassa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Agennix

INDUSTRY

NCT00630656 - Safety and Efficacy Study of Recombinant Human Lactoferrin to Treat Severe Sepsis | Biotech Hunter | Biotech Hunter