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

Phase 3TerminatedNCT00037687

ICOS Corporation2,500 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,500

Conditions

Sepsis

Interventions

rPAF-AHDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mary E. Lonien, M.S.

Bothell, Washington, United States

Data from ClinicalTrials.gov

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