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

ICOS Corporation

Status and phase

Terminated

Phase 3

Conditions

Sepsis

Treatments

Drug: rPAF-AH

Study type

Interventional

Funder types

Industry

Identifiers

NCT00037687

BB-IND 9538

BAR03

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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