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