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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00037687
Recruitment Status : Terminated
First Posted : May 21, 2002
Last Update Posted : June 24, 2005
Suntory Pharmaceutical
Information provided by:
ICOS Corporation

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 Type : Interventional  (Clinical Trial)
Enrollment : 2500 participants
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 : April 2001
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00037687

United States, Washington
Mary E. Lonien, M.S.
Bothell, Washington, United States, 98021
Sponsors and Collaborators
ICOS Corporation
Suntory Pharmaceutical

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. Identifier: NCT00037687     History of Changes
Other Study ID Numbers: BAR03
BB-IND 9538
First Posted: May 21, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2003

Keywords provided by ICOS Corporation:
Severe sepsis
Platelet-activating factor acetylhydrolase

Additional relevant MeSH terms:
Systemic Inflammatory Response Syndrome
Pathologic Processes