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 Details — Status: Terminated

Administrative data

• NCT number: NCT00037687
• Other study ID #: BAR03
• Secondary ID: BB-IND 9538
• Status: Terminated
• Phase: Phase 3
• First received: May 20, 2002
• Last updated: June 23, 2005
• Start date: April 2001
• Est. completion date: December 2004

Study information

• Verified date: January 2003
• Source: ICOS Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2500
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Drug:
• rPAF-AH

Locations

Country	Name	City	State
United States	Mary E. Lonien, M.S.	Bothell	Washington

Sponsors (2)

Lead Sponsor	Collaborator
ICOS Corporation	Suntory Pharmaceutical

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.