A Study of Varespladib Infusion in Subjects With Sickle Cell Disease. (IMPACTS-2)

January 30, 2014 updated by: Anthera Pharmaceuticals

A Randomized, Double-blind, Placebo-Controlled Study With Varespladib Infusion (A-001) in Subjects With Sickle Cell Disease and Vaso-Occlusive Crisis for the Prevention of Acute Chest Syndrome At-Risk Subjects.

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Investigator Site 101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Varespladib
48 hour continuous infusion delivered intravenously (IV)
Drug: Varespladib
48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.
Placebo Comparator: Placebo
48 hour continuous infusion delivered intravenously (IV)
Other: Placebo (Normal Saline)
48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of A 001 infusion in preventing acute chest syndrome in sickle cell disease (SCD) subjects with the combination of vaso-occlusive crisis, fever, and elevated serum C-reactive protein (CRP).
Time Frame: Various time points up to Day 30
Various time points up to Day 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome.
Time Frame: Various time points up to Day 30
Various time points up to Day 30
Impact of A-001 treatment on sPLA2 levels and CRP.
Time Frame: Various time points up to Day 30
Various time points up to Day 30
Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis.
Time Frame: Various time points up to Day 30
Various time points up to Day 30
Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis.
Time Frame: Various time points up to Day 30
Various time points up to Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anthera Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

January 31, 2012

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

January 30, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN-SCD1122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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