Anti-TF Antibody (ALT-836) to Treat Septic Patients With Acute Lung Injury or Acute Respiratory Distress Syndrome
Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
Participant gender:
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.