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Methods: The RESET trial (NCT02187003) was a phase 3, randomized, double-blind, controlled study of rivipansel for VOC requiring hospitalization. Three hundred forty-five patients (204 adults and 141 subjects 6-17 years… Click to show full abstract
Methods: The RESET trial (NCT02187003) was a phase 3, randomized, double-blind, controlled study of rivipansel for VOC requiring hospitalization. Three hundred forty-five patients (204 adults and 141 subjects 6-17 years old) were randomized to an intravenous rivipansel loading dose, followed by ≤14 additional doses Q 12 hr, or placebo, in addition to standard care. Overall, 162 were treated with rivipansel and 158 with placebo. The primary endpoint was time-to-readiness-for-discharge (TTRFD), and key secondary endpoints were time-to-discharge (TTD), time-to-discontinuation-of-IV-opioids (TTDIVO), and cumulative-IV-opioid-use (CIVO).
Journal Title: Blood
Year Published: 2020
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