Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome

PHASE2CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

October 31, 2012

Study Completion Date

January 31, 2013

Conditions
SepsisAcute Lung InjuryAcute Respiratory Distress Syndrome
Interventions
DRUG

ALT-836

In the first part of this study, recombinant chimeric anti-tissue factor antibody ALT-836 was administered as a single dose (0.06 mg/Kg) via intravenous infusion over 15 minutes. In the second part of this study, up to four doses (0.06 mg/Kg) of ALT-836 will be administered via intravenous infusion over 15 minutes.

DRUG

Placebo

In the first part of this study, a single dose of Placebo was administered via intravenous infusion over 15 minutes. In the second part of this study, up to four doses of Placebo will be administered via intravenous infusion over 15 minutes.

Trial Locations (20)

10029

Mount Sinai Medical Center, New York

10065

Memorial Sloan-Kettering Cancer Center, New York

27157

Wake Forest University, Winston-Salem

27310

Piedmont Respiratory Research Foundation, Greensboro

28203

Carolinas Medical Center, Charlotte

40202

University of Louisville-Division of Pulmonary and Critical Care, Louisville

41701

Kentucky Lung Clinic, Hazard

52246

University of Iowa, Iowa City

60302

West Suburban Hospital Medical Center, Oak Park

60611

Northwestern University, Chicago

61606

Illinois Lung and Critical Care Institute, Peoria

63110

Saint Louis University, St Louis

63141

Mercy Hospital St. Louis, St Louis

64111

Saint Luke's Hospital, Kansas City

73104

University of Oklahoma, Oklahoma City

90033

Los Angeles County and USC Medical Center, Los Angeles

94305

Stanford University, Stanford

95817

UC Davis Medical Center, Sacramento

06520

Yale University, New Haven

01199

Baystate Medical Center, Springfield

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Altor BioScience

INDUSTRY