Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis who are admitted to the hospital for treatment.
A single-blind, multicenter, randomized, placebo-control study in which 30 Sickle Cell disease patients having a vaso-occlusive crisis will either receive SANGUINATE 320 mg/kg/patient (8 mL/kg/patient) or Normal Saline on Day 1 (Visit 1) and Day 2 (Visit 2) infused over 2 hours each day. Patients are to remain in the hospital for up to 7 days but can be discharged at any time after receiving the second dose of SANGUINATE, provided their vaso-occlusive crisis has resolved and the patient has completed discharge procedures. Patients will have a follow-up phone call 7 days after discharge from the hospital to obtain safety, concomitant medication and pain assessments.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
Two-hour infusion of SANGUINATE on Day 1 and Day 2
Two-hour infusion of Normal Saline and Day 1 and Day 2
Unnamed facility
Bogotá, Colombia
Unnamed facility
Santo Domingo, Dominican Republic
Unnamed facility
San Pedro Sula, Honduras
Unnamed facility
Panama City, Panama
Time to readiness for discharge from in hospital stay following treatment with SANGUINATE and Normal Saline.
Defined as the patient's response that their pain episode has improved enough for discharge from the hospital, or the Investigator's assessment that the patient is ready for discharge from the hospital.
Time frame: Up to 7 Days
Safety of treatment as defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, as well as reported increases in pain and other reported adverse events
Composite endpoint with multiple vital signs, ECGs, echocardiograms, clinical assessments and bio-analytical lab measurements over the 7 day time frame
Time frame: Up to 7 Days
Proportion of patients who develop acute chest syndrome (ACS) during the study.
Time frame: Up to 14 Days
Proportion of patients who are re-hospitalized for their vaso-occlusive crisis episode.
Time frame: Up to 7 Days
Total length of stay (LOS) following treatment of SANGUINATE versus Normal Saline.
Time frame: Up to 7 Days
Percent reduction in total pain medication required during in-hospital stay following treatment with SANGUINATE and Normal Saline.
Time frame: Up to 7 Days
Percent reduction in pain score utilizing a visual analog scale following treatment with SANGUINATE and Normal Saline.
Time frame: Up to 7 Days
Reduction in the level of C-Reactive Protein following treatment of SANGUINATE versus Normal Saline.
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Time frame: Up to 7 Days