Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
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ClinicalTrials.gov Identifier: NCT00879606 |
Recruitment Status
:
Completed
First Posted
: April 10, 2009
Last Update Posted
: April 10, 2015
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Condition or disease | Intervention/treatment | Phase |
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Sepsis Acute Lung Injury Acute Respiratory Distress Syndrome | Drug: ALT-836 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety Evaluation of ALT-836 in Patients With Sepsis and Acute Lung Injury/Acute Respiratory Distress Syndrome |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | October 2012 |
Actual Study Completion Date : | January 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Participants will be randomized to receive ALT-836.
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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.
Other Name: Formerly TNX-832; Sunol-cH36
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Placebo Comparator: 2
Patients will be randomized to receive placebo.
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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.
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- Safety profile of the study drug [ Time Frame: Throughout the 28 days following treatment ]
- Number of ventilator-free days at Day 28 [ Time Frame: Determined at Day 28 ]
- Mortality at Day 7, 14, 21, 28 and 60 [ Time Frame: Determined at Day 7, 14, 21, 28 and 60 ]
- Length of hospitalization at Day 28 [ Time Frame: Determined at Day 28 ]
- Length of ICU stay at Day 28 [ Time Frame: Determined at Day 28 ]
- Number of Non-pulmonary organ failure free days at Day 28 [ Time Frame: Determined at Day 28 ]
- Changes in physiological variables of lung injury [ Time Frame: Throughout the 28 days following treatment ]
- Changes in disease severity and lung injury scores [ Time Frame: Throughout the 28 days following treatment ]
- Effects of the study drug and the etiology of the disease (i.e. pulmonary or extra-pulmonary origin) [ Time Frame: Determined at Day 28 ]
- Pharmacokinetics & Pharmacodynamics [ Time Frame: Throughout the 28 days following treatment ]
- Immunogenicity [ Time Frame: Throughout the 28 days following treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
- 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.
EXCLUSION CRITERIA:
- <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
- Stroke within 3 months of study entry
- Trauma with an increased risk of life-threatening bleeding
- A history of severe head trauma that required hospitalization, or intracranial surgery within two months of study entry
- Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion
- Uses of certain medications or treatment regimens such as chemotherapy, unfractionated heparin, low-molecular-weight heparin, Warfarin, antithrombin III, acetylsalicylic acid, glycoprotein IIb/IIIa antagonists, thrombolytic therapy, and activated Protein C are restricted.
- Participation in another experimental medication study within 30 days of study entry.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879606
United States, California | |
Los Angeles County and USC Medical Center | |
Los Angeles, California, United States, 90033 | |
UC Davis Medical Center | |
Sacramento, California, United States, 95817 | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06520 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611 | |
West Suburban Hospital Medical Center | |
Oak Park, Illinois, United States, 60302 | |
Illinois Lung and Critical Care Institute | |
Peoria, Illinois, United States, 61606 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52246 | |
United States, Kentucky | |
Kentucky Lung Clinic | |
Hazard, Kentucky, United States, 41701 | |
University of Louisville-Division of Pulmonary and Critical Care | |
Louisville, Kentucky, United States, 40202 | |
United States, Massachusetts | |
Baystate Medical Center | |
Springfield, Massachusetts, United States, 01199 | |
United States, Missouri | |
Saint Luke's Hospital | |
Kansas City, Missouri, United States, 64111 | |
Saint Louis University | |
St. Louis, Missouri, United States, 63110 | |
Mercy Hospital St. Louis | |
St. Louis, Missouri, United States, 63141 | |
United States, New York | |
Mount Sinai Medical Center | |
New York City, New York, United States, 10029 | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10065 | |
United States, North Carolina | |
Carolinas Medical Center | |
Charlotte, North Carolina, United States, 28203 | |
Piedmont Respiratory Research Foundation | |
Greensboro, North Carolina, United States, 27310 | |
Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Oklahoma | |
University of Oklahoma | |
Oklahoma City, Oklahoma, United States, 73104 |
Study Chair: | Hing C Wong, PhD | Altor BioScience |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Altor BioScience |
ClinicalTrials.gov Identifier: | NCT00879606 History of Changes |
Other Study ID Numbers: |
CA-ALT-836-01-08 NHLBI/NIH-5R44HL082397-03 |
First Posted: | April 10, 2009 Key Record Dates |
Last Update Posted: | April 10, 2015 |
Last Verified: | March 2015 |
Keywords provided by Altor BioScience:
Sepsis Acute Lung Injury Acute Respiratory Distress Syndrome ALI/ARDS Lung Disease |
Additional relevant MeSH terms:
Syndrome Wounds and Injuries Sepsis Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Disease Pathologic Processes Infection Systemic Inflammatory Response Syndrome |
Inflammation Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Immunoglobulin G Immunologic Factors Physiological Effects of Drugs |