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

This study has been terminated.
Sponsor:
Collaborator:
Suntory Pharmaceutical
Information provided by:
ICOS Corporation
ClinicalTrials.gov Identifier:
NCT00037687
First received: May 20, 2002
Last updated: June 23, 2005
Last verified: January 2003
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

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.

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

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

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013