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



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

For Condition: Sepsis
Status: Terminated
Sponsor(s): ICOS , Suntory Pharmaceutical
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 2500

Location and Contact Information:

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


Additional Information:
Study ID Numbers:
  BAR03;  BB-IND 9538
Study Start Date: April 2001
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00037687

Other Sepsis Studies:
1. Safety and Efficacy of MBI 226 for the Prevention of Central Venous Catheter-related Bloodstream Infections

2. A Phase IIb Study to Determine the Efficacy and Safety of the Study Drug in Patients with Severe Sepsis

3. Effects of Endotoxin in Normal Human Volunteers

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

5. The Study of Drotrecogin Alfa (Activated) in a Subpopulation of Adult Patients with Severe Sepsis

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

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