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NCT00879606 · ClinicalTrials.gov registry record · Phase 2
Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
A Phase 2 study of Sepsis and Acute Respiratory Distress Syndrome, sponsored by Altor BioScience.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT00879606 is a Phase 2 study of Sepsis and Acute Respiratory Distress Syndrome that has completed, run by Altor BioScience. The registered enrollment target is 150 participants, below the 6,563-participant average among 90 other Sepsis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT00879606, a Phase 2 study of Sepsis and Acute Respiratory Distress Syndrome, has completed, sponsored by Altor BioScience.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ALT-836
Study Locations (20)
California
- Los Angeles County and USC Medical Center - Los Angeles
- UC Davis Medical Center - Sacramento
- Stanford University - Stanford
Illinois
- Northwestern University - Chicago
- West Suburban Hospital Medical Center - Oak Park
- Illinois Lung and Critical Care Institute - Peoria
Missouri
- Saint Luke's Hospital - Kansas City
- Saint Louis University - St Louis
- Mercy Hospital St. Louis - St Louis
North Carolina
- Carolinas Medical Center - Charlotte
- Piedmont Respiratory Research Foundation - Greensboro
- Wake Forest University - Winston-Salem
Kentucky
- Kentucky Lung Clinic - Hazard
- University of Louisville-Division of Pulmonary and Critical Care - Louisville
New York
- Mount Sinai Medical Center - New York
- Memorial Sloan-Kettering Cancer Center - New York
Connecticut
- Yale University - New Haven
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2009-04 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00879606
The ClinicalTrials.gov registry entry for NCT00879606 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,563-participant average among 90 other Sepsis trials with a reported enrollment target (98% lower). The listed sponsor is Altor BioScience, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Sepsis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00879606 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Illinois, Missouri.
Frequently Asked Questions
What is clinical trial NCT00879606 about?
NCT00879606 is a clinical study titled "Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome". 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). Th...
What is the current status of trial NCT00879606?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2009-04. Estimated completion is 2013-01.
What conditions does trial NCT00879606 study?
This clinical trial studies the following conditions: Sepsis, Acute Respiratory Distress Syndrome, Acute Lung Injury.
What interventions are being tested in trial NCT00879606?
The interventions under investigation include: Placebo (DRUG), ALT-836 (DRUG).
Who is sponsoring clinical trial NCT00879606?
This trial is sponsored by Altor BioScience, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00879606 being conducted?
This trial has 20 study locations across California, Connecticut, Illinois, Iowa, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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