Status:
COMPLETED
IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome
Lead Sponsor:
Anthera Pharmaceuticals
Conditions:
Sickle Cell Disease
Vaso-occlusive Crisis
Eligibility:
All Genders
5+ years
Phase:
PHASE2
Brief Summary
The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syn...
Detailed Description
This is a double-blind randomized, parallel group, placebo-controlled dose escalation study (2 cohorts) in patients with sickle cell disease (SCD) and vaso-occlusive crisis (VOC) who are at-risk for d...
Eligibility Criteria
Inclusion
- Patients are eligible for inclusion if they meet the following criteria:
- Sickle cell variant (Hb SS, Hb SC, sickle β°-thalassemia, sickle β+-thalassemia)
- Pain consistent with vaso-occlusive crisis
- Elevated serum sPLA2 level (measured on-site)
- Fever
- Age ≥5 years (through adult)
- Patients must NOT meet any of the following 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00434473
Start Date
December 1 2006
End Date
December 1 2009
Last Update
March 4 2014
Active Locations (6)
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1
Howard University Hospital
Washington D.C., District of Columbia, United States, 20060
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
3
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
4
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203