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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014