A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.
Phase 2
Terminated
- Conditions
- Sickle Cell DiseaseVaso-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
Group Intervention Description Placebo Placebo (Normal Saline) 48 hour continuous infusion delivered intravenously (IV) Varespladib Varespladib 48 hour continuous infusion delivered intravenously (IV)
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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