A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.

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

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-03-31

Brief Summary

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The purpose of this study is to determine the effectiveness of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).

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Detailed Description

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Conditions

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Sickle Cell Disease Vaso-occlusive Crisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Varespladib

48 hour continuous infusion delivered intravenously (IV)

Group Type ACTIVE_COMPARATOR

Varespladib

Intervention Type DRUG

48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.

Placebo

48 hour continuous infusion delivered intravenously (IV)

Group Type PLACEBO_COMPARATOR

Placebo (Normal Saline)

Intervention Type OTHER

48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.

Interventions

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Varespladib

48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.

Intervention Type DRUG

Placebo (Normal Saline)

48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Genotypes Hb SS, Hb SC, sickle β°-thalassemia, sickle β+ -thalassemia
* Pain consistent with vaso-occlusive crisis (clinical judgment) and not attributable to other causes
* Serum CRP ≥5.0 mg/L at time of screening
* Fever defined as oral temperature ≥38.0°C at time of screening
* Age ≥5 years

Exclusion Criteria

* New or suspected new pulmonary infiltrate diagnosed by chest radiography
* Females who are nursing, pregnant or intend to become pregnant
* Renal dysfunction defined as a creatinine level \>1.2 mg/dL for subjects aged 18 or less or a creatinine level \>1.5 mg/dL for subjects over the age of 18
* Hepatic dysfunction (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>3 × upper limit of normal)
* Acute neurologic dysfunction
* Any medical condition for which transfusion may be needed imminently, and/or hemoglobin \<5 g/dL
* Red blood cell transfusion within 30 days prior to screening
* Parenteral or oral corticosteroid therapy (inhaled steroids acceptable) within 7 days prior to screening

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No