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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis

Keywords

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Severe sepsis Platelet-activating factor acetylhydrolase

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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rPAF-AH

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Mary E. Lonien, M.S.

Bothell, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

Other Identifiers

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BB-IND 9538

Identifier Type: -

Identifier Source: secondary_id

BAR03