Contact Information
Project Manager:
Georgina Kilfoil
Anthera Pharmaceuticals, Inc.
T: 510.856.5578
F: 510-856-5597
E: gkilfoil@anthera.com
Investigation of the Modulation of Phospholipase in Acute ChesT Syndrome
Purpose
This Phase 2 multi–center trial is evaluating the safety and effectiveness of intravenous A–001 (varespladib sodium) in preventing the development of acute chest syndrome in hospitalized sickle cell disease patients. Enrolled patients will be those at–risk for acute chest syndrome based on the combination of pain (vaso–occlusive crisis)‚ fever‚ and elevated serum level of the enzyme (secretory phospholipase).
Eligibility
Patients are eligible for inclusion if they meet the following criteria:
- Sickle cell variant (Hb SS, Hb SC, sickle ß°—thalassemia, sickle ß+ —thalassemia)
- Pain consistent with vaso-occlusive crisis
- Elevated serum level (measured on-site)
- Fever
- Age > 5 years (through adult)
Exclusion Criteria
Patients must not meet any of the following (principal) exclusion criteria:
- New lung infiltrate by chest radiography
- Pregnancy or breastfeeding
- Significant renal dysfunction
- Significant hepatic dysfunction
- 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 of entry into the study
Endpoints
The main efficacy endpoint is freedom from the development of acute chest syndrome.
Location
Approximately 15 U.S. centers.
