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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
2
48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.
48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.
Investigator Site 101
Atlanta, Georgia, United States
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).
Time frame: Various time points up to Day 30
Safety and tolerability of A 001 therapy when administered as a 48-hour continuous infusion to SCD subjects at-risk for acute chest syndrome.
Time frame: Various time points up to Day 30
Impact of A-001 treatment on sPLA2 levels and CRP.
Time frame: Various time points up to Day 30
Impact of A-001 treatment on the signs and symptoms of vaso-occlusive crisis.
Time frame: Various time points up to Day 30
Impact of A-001 treatment on opioid use for pain in the treatment of vaso-occlusive crisis.
Time frame: Various time points up to Day 30
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