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

• Status: Terminated
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ICOS Corporation
• Collaborator: Suntory Pharmaceutical

Criteria

Inclusion criteria

• Clinical diagnosis of severe sepsis

• At least 18 years old

• Patient or legally authorized representative able to provide informed consent

Exclusion criteria

• Severe lung injury (acute respiratory distress syndrome)

• Immunocompromised

• Severe liver disease

• Inflammation of the pancreas, organ rejection, or burns to more than 30% of body

• Enrolled in another clinical trial

• Already participated in this or other rPAF-AH study

• There is not a commitment to aggressive treatment

• Has a disease with life expectancy less than 6 months