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

• Sponsor: ICOS Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00037687
• Collaborator: Suntory Pharmaceutical (Industry)
• Enrollment: 2,500
• Location: 1
• Duration (Months): 44
• Patients Per Site Per Month: 56.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Drug: rPAF-AH	Phase 3

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• 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
• Study Start Date: Apr 1, 2001
• Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mary E. Lonien, M.S.	Bothell	Washington	United States	98021

Sponsors and Collaborators

• ICOS Corporation
• Suntory Pharmaceutical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT00037687
• Other Study ID Numbers: BAR03; BB-IND 9538
• First Posted: May 21, 2002
• Last Update Posted: Jun 24, 2005
• Last Verified: Jan 1, 2003

• Keywords provided by , ,: Severe sepsis; Platelet-activating factor acetylhydrolase
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Jun 24, 2005