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

Completed · Phase 2 · Has a placebo group

Conditions studied: Sepsis, Acute Lung Injury, Acute Respiratory Distress Syndrome

In brief

This is a prospective, randomized (1:1), double-blind, multi-center, Phase II clinical study to test the safety and efficacy of a recombinant chimeric anti-tissue factor antibody (ALT-836) versus placebo in patients with sepsis and acute lung injury/acute respiratory distress syndrome (ALI/ARDS). This study was divided into two parts and the first part of the study has been completed. In the first part of the study, sixty patients were randomized at a 1:1 ratio to receive one dose of the study drug or placebo. In the second part of the study, ninety patients will be randomized at a 1:1 ratio to receive a multi-dose treatment regimen of single doses every 72 hours up to a maximum of 4 doses of the study drug or placebo, provided there are no safety concerns.

Key facts

Study ID

NCT00879606

Run by

Altor BioScience

People needed

150

Starts

2009-04-01

Expected to finish

2013-01-01

Last updated by the study team

2015-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Suspected or proven infection
• Hypoxemia: PaO2/FiO2is ≤300 mm Hg
• Bilateral infiltrates consistent with pulmonary edema
• Positive-pressure mechanical ventilation through an endotracheal tube
• No clinical evidence of left atrial hypertension to explain bilateral infiltrates
• Presence of at least three of the four SIRS criteria. If only two criteria are evidenced, one must be temperature or WBC
• Criteria 2 and 3 must occur within a 24-hour interval. The 48-hour enrollment time window begins when criteria 2, 3, and 4 are met.

You may not qualify if…

• <18 years
• Inability to obtain consent
• Patient, surrogate, or physician not committed to full support
• Moribund state in which death was perceived to be imminent
• Morbid obesity
• Malignancy or other irreversible disease or condition for which 6-month mortality is estimated to be >50%
• Known HIV positive with known end stage processes
• Prior cardiac arrest requiring CPR without fully demonstrated neurological recovery; or New York Heart Association Class IV
• Pregnant or nursing
• ALI/ARDS induced by mechanical or chemical injury directly to the lung (including burns, trauma, and near drowning)
• >48 hours since all inclusion criteria are met
• Neuromuscular disease that impairs ability to ventilate without assistance
• Severe chronic respiratory disease, severe pulmonary hypertension, or ventilator dependency
• Chest wall deformity resulting in severe exercise restriction, secondary polycythemia, or respirator dependent
• History of organ transplant (including bone marrow)
• Severe chronic liver disease, as determined by a Child-Pugh Score >10
• Hemoglobin persistently < 7.0 g/dL
• Platelet count <50,000/mm3
• Prolonged INR >3
• Bleeding disorders unless corrective surgery has been performed
• Active internal bleeding
• Major surgery within 24 hours before study drug infusion, or evidence of active bleeding postoperatively, or plan for any major surgery within 3 days after study drug infusion.
• Diffuse alveolar hemorrhage from vasculitis
• Known bleeding diathesis
• Presence of an epidural catheter or lumbar puncture within 48 hours before study drug infusion or anticipation of receiving an epidural catheter or a lumbar puncture within 48 hours after study drug infusion

Where it is running

• Los Angeles County and USC Medical Center — Los Angeles, California, United States
• UC Davis Medical Center — Sacramento, California, United States
• Stanford University — Stanford, California, United States
• Yale University — New Haven, Connecticut, United States
• Northwestern University — Chicago, Illinois, United States
• West Suburban Hospital Medical Center — Oak Park, Illinois, United States
• Illinois Lung and Critical Care Institute — Peoria, Illinois, United States
• University of Iowa — Iowa City, Iowa, United States
• Kentucky Lung Clinic — Hazard, Kentucky, United States
• University of Louisville-Division of Pulmonary and Critical Care — Louisville, Kentucky, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• Saint Luke's Hospital — Kansas City, Missouri, United States
• Saint Louis University — St Louis, Missouri, United States
• Mercy Hospital St. Louis — St Louis, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• Memorial Sloan-Kettering Cancer Center — New York, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Piedmont Respiratory Research Foundation — Greensboro, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• University of Oklahoma — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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