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

Phase 2
Terminated
Conditions
Sickle Cell Disease
Vaso-occlusive Crisis
Interventions
Other: Placebo (Normal Saline)
Drug: Varespladib
Registration Number
NCT01522196
Lead Sponsor
Anthera Pharmaceuticals
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
2
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo (Normal Saline)48 hour continuous infusion delivered intravenously (IV)
VarespladibVarespladib48 hour continuous infusion delivered intravenously (IV)
Primary Outcome Measures
NameTimeMethod
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).Various time points up to Day 30
Secondary Outcome Measures
NameTimeMethod
Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome.Various time points up to Day 30
Impact of A-001 treatment on sPLA2 levels and CRP.Various time points up to Day 30
Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis.Various time points up to Day 30
Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis.Various time points up to Day 30

Trial Locations

Locations (1)

Investigator Site 101

🇺🇸

Atlanta, Georgia, United States

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