Status:
TERMINATED
A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.
Lead Sponsor:
Anthera Pharmaceuticals
Conditions:
Sickle Cell Disease
Vaso-occlusive Crisis
Eligibility:
All Genders
5+ years
Phase:
PHASE2
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01522196
Start Date
February 1 2012
End Date
March 1 2012
Last Update
March 4 2014
Active Locations (1)
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1
Investigator Site 101
Atlanta, Georgia, United States, 30342