drugset / Trial / NCT00037687

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

NCT00037687 ↗

Phase 3 Terminated 2500 enrolled ICOS Corporation Suntory Pharmaceutical · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2001-04
Primary completion
—
Completion
2004-12

Publications

  • Background The Pafase Phase II ARDS Prevention Study Group. Recombinant platelet-activating factor acetylhydrolase (Pafase) decreases the incidence of acute respiriatory distress syndrome (ARDS) and 28 day all cause mortality (Abstract). Intensive Care Med (2000); 26: S321.

Drugs

EvaluationDrugModalityDoseRoute
Subject EPAFIPASE Protein / enzyme biologic — Intravenous