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

This study has been terminated.

First Received: May 20, 2002 Last Updated: June 23, 2005 History of Changes

Sponsor:	ICOS Corporation
Collaborator:	Suntory Pharmaceutical
Information provided by:	ICOS Corporation
ClinicalTrials.gov Identifier:	NCT00037687

Purpose

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	Intervention	Phase
Sepsis	Drug: rPAF-AH	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Further study details as provided by ICOS Corporation:

Estimated Enrollment:	2500
Study Start Date:	April 2001
Estimated Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037687

Locations

United States, Washington
Mary E. Lonien, M.S.
Bothell, Washington, United States, 98021

Sponsors and Collaborators

ICOS Corporation

Suntory Pharmaceutical

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.

Study ID Numbers:	BAR03, BB-IND 9538
Study First Received:	May 20, 2002
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00037687 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ICOS Corporation:

Severe sepsis
Platelet-activating factor acetylhydrolase

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Sepsis
Pathologic Processes
Infection
Inflammation

ClinicalTrials.gov processed this record on November 27, 2009