NCT00037687

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,500 (planned)
• Sponsor: ICOS Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	rPAF-AH

Timeline

• Start date: 2001-04-01
• Completion: 2004-12-01
• First posted: 2002-05-21
• Last updated: 2005-06-24

Locations

1 site across 1 country: United States