Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
Public ClinicalTrials.gov record NCT00879606. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy and Safety Evaluation of ALT-836 in Patients With Sepsis and Acute Lung Injury/Acute Respiratory Distress Syndrome
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00879606
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 150 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2009 (Type not available)
- Primary completion
- Oct 2012 (Actual)
- Completion
- Jan 2013 (Actual)
- Last update posted
- Apr 10, 2015
2009 – 2013
United States locations
- U.S. sites
- 20
- U.S. states
- 10
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Los Angeles County and USC Medical Center | Los Angeles | California | 90033 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| Stanford University | Stanford | California | 94305 | — |
| Yale University | New Haven | Connecticut | 06520 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| West Suburban Hospital Medical Center | Oak Park | Illinois | 60302 | — |
| Illinois Lung and Critical Care Institute | Peoria | Illinois | 61606 | — |
| University of Iowa | Iowa City | Iowa | 52246 | — |
| Kentucky Lung Clinic | Hazard | Kentucky | 41701 | — |
| University of Louisville-Division of Pulmonary and Critical Care | Louisville | Kentucky | 40202 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| Saint Louis University | St Louis | Missouri | 63110 | — |
| Mercy Hospital St. Louis | St Louis | Missouri | 63141 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Piedmont Respiratory Research Foundation | Greensboro | North Carolina | 27310 | — |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | — |
| University of Oklahoma | Oklahoma City | Oklahoma | 73104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00879606, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 10, 2015 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00879606 live on ClinicalTrials.gov.