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Safety and Efficacy of Recombinant Human Platelet-Activating Factor Acetylhydrolase for the Treatment of Severe Sepsis

Sepsis Clinical Trial

Official title:
A Phase 3 Study to Demonstrate the Safety and Efficacy of Recombinant Platelet-Activating Factor Acetylhydrolase (rPAF-AH, Pafase®) for Reducing 28 Day All Cause Mortality in Patients With Severe Sepsis

Clinical Trial Summary

The objective of this study is to demonstrate that rPAF-AH is safe and reduces 28 day all cause mortality in patients with severe sepsis.

Clinical Trial Description

This study is a randomized, double-blind, placebo-controlled, multicenter study of rPAF-AH compared to placebo in patients with severe sepsis. Eligible patients from investigative sites located throughout the United States and other countries will be randomized to receive either rPAF-AH or placebo administered daily for five consecutive days by intravenous (IV) infusion. All patients will be evaluated for safety and efficacy endpoints over 28 days. A follow-up evaluation will occur approximately 6 months after Day 28 to assess functional status and quality of life. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00037687
Study type Interventional
Source ICOS Corporation
Contact
Status Terminated
Phase Phase 3
Start date April 2001
Completion date December 2004
View Details
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