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COMPLETED Phase 2

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

NCT00879606 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 150 participants
Start Date 2009-04
Est. Completion 2013-01
Phase Phase 2

Sponsor

Altor BioScience

3 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Altor BioScience, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00879606 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Illinois, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00879606?

The interventions under investigation include: Placebo (DRUG), ALT-836 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00879606?

This trial is sponsored by Altor BioScience, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial