Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
Efficacy and Safety Evaluation of ALT-836 in Patients With Sepsis and Acute Lung Injury/Acute Respiratory Distress Syndrome
2 other identifiers
interventional
150
1 country
20
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 sepsis
Started Apr 2009
Longer than P75 for phase_2 sepsis
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 8, 2009
CompletedFirst Posted
Study publicly available on registry
April 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedApril 10, 2015
March 1, 2015
3.5 years
April 8, 2009
March 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety profile of the study drug
Throughout the 28 days following treatment
Number of ventilator-free days at Day 28
Determined at Day 28
Secondary Outcomes (9)
Mortality at Day 7, 14, 21, 28 and 60
Determined at Day 7, 14, 21, 28 and 60
Length of hospitalization at Day 28
Determined at Day 28
Length of ICU stay at Day 28
Determined at Day 28
Number of Non-pulmonary organ failure free days at Day 28
Determined at Day 28
Changes in physiological variables of lung injury
Throughout the 28 days following treatment
- +4 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALParticipants will be randomized to receive ALT-836.
2
PLACEBO COMPARATORPatients will be randomized to receive placebo.
Interventions
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.
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.
Eligibility Criteria
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)
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Los Angeles County and USC Medical Center
Los Angeles, California, 90033, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
Stanford University
Stanford, California, 94305, United States
Yale University
New Haven, Connecticut, 06520, United States
Northwestern University
Chicago, Illinois, 60611, United States
West Suburban Hospital Medical Center
Oak Park, Illinois, 60302, United States
Illinois Lung and Critical Care Institute
Peoria, Illinois, 61606, United States
University of Iowa
Iowa City, Iowa, 52246, United States
Kentucky Lung Clinic
Hazard, Kentucky, 41701, United States
University of Louisville-Division of Pulmonary and Critical Care
Louisville, Kentucky, 40202, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Saint Luke's Hospital
Kansas City, Missouri, 64111, United States
Saint Louis University
St Louis, Missouri, 63110, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Piedmont Respiratory Research Foundation
Greensboro, North Carolina, 27310, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
Related Publications (1)
Morris PE, Steingrub JS, Huang BY, Tang S, Liu PM, Rhode PR, Wong HC. A phase I study evaluating the pharmacokinetics, safety and tolerability of an antibody-based tissue factor antagonist in subjects with acute lung injury or acute respiratory distress syndrome. BMC Pulm Med. 2012 Feb 16;12:5. doi: 10.1186/1471-2466-12-5.
PMID: 22340260DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hing C Wong, PhD
Altor BioScience
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2009
First Posted
April 10, 2009
Study Start
April 1, 2009
Primary Completion
October 1, 2012
Study Completion
January 1, 2013
Last Updated
April 10, 2015
Record last verified: 2015-03