A Study of Varespladib Infusion in Subjects With Sickle Cell Disease.
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Sickle Cell Disease, Vaso-occlusive Crisis
In brief
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).
Key facts
- Study ID
- NCT01522196
- Run by
- Anthera Pharmaceuticals
- People needed
- 2
- Starts
- 2012-02-01
- Expected to finish
- 2012-03-01
- Last updated by the study team
- 2014-03-04
Who can join
Age: 5 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Investigator Site 101 — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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