{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T18:14:12Z","timestamp":1792088052670,"version":"4.4.0"},"reference-count":23,"publisher":"American Society of Hematology","issue":"2","content-domain":{"domain":["ashpublications.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2023,1,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>The efficacy and safety of rivipansel, a predominantly E-selectin antagonist, were studied in a phase 3, randomized, controlled trial for vaso-occlusive crisis (VOC) requiring hospitalization (RESET). A total of 345 subjects (204 adults and 141 children) were randomized and 320 were treated (162 with rivipansel, 158 with placebo) with an IV loading dose, followed by up to 14 additional 12-hourly maintenance doses of rivipansel or placebo, in addition to standard care. Rivipansel was similarly administered during subsequent VOCs in the Open-label Extension (OLE) study. In the full analysis population, the median time to readiness for discharge (TTRFD), the primary end point, was not different between rivipansel and placebo (\u22125.7 hours, P\u00a0= .79; hazard ratio, 0.97), nor were differences seen in secondary end points of time to discharge (TTD), time to discontinuation of IV opioids (TTDIVO), and cumulative IV opioid use. Mean soluble E-selectin decreased 61% from baseline after the loading dose in the rivipansel group, while remaining unchanged in the placebo group. In a post hoc analysis, early rivipansel treatment within 26.4 hours of VOC pain onset (earliest quartile of time from VOC onset to treatment) reduced median TTRFD by 56.3 hours, reduced median TTD by 41.5 hours, and reduced median TTDIVO by 50.5 hours, compared with placebo (all P\u00a0&amp;lt; .05). A similar subgroup analysis comparing OLE early-treatment with early-treatment RESET placebo showed a reduction in TTD of 23.1\u00a0hours (P\u00a0= .062) and in TTDIVO of 30.1 hours (P\u00a0=\u00a0.087). Timing of rivipansel administration after pain onset may be critical to achieving accelerated resolution of acute VOC. Trial Registration: Clinicaltrials.gov, NCT02187003 (RESET), NCT02433158 (OLE).<\/jats:p>","DOI":"10.1182\/blood.2022015797","type":"journal-article","created":{"date-parts":[[2022,8,18]],"date-time":"2022-08-18T19:02:36Z","timestamp":1660849356000},"page":"168-179","update-policy":"https:\/\/doi.org\/10.1182\/blood.2019cm0000","source":"Crossref","is-referenced-by-count":40,"title":["A randomized clinical trial of the efficacy and safety of rivipansel for sickle cell vaso-occlusive crisis"],"prefix":"10.1182","volume":"141","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7738-2620","authenticated-orcid":false,"given":"Carlton D.","family":"Dampier","sequence":"first","affiliation":[{"name":"1Department of Pediatrics, Emory University, Atlanta, GA"},{"name":"2Aflac Cancer and Blood Disorders Center, Atlanta, GA"},{"name":"3Children\u2019s Healthcare of Atlanta, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3809-1780","authenticated-orcid":false,"given":"Marilyn Jo","family":"Telen","sequence":"additional","affiliation":[{"name":"4Division of Hematology, Duke Comprehensive Sickle Cell Center, Duke University Medical Center, Durham, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6383-7172","authenticated-orcid":false,"given":"Ted","family":"Wun","sequence":"additional","affiliation":[{"name":"5Division of Hematology Oncology, UC Davis School of Medicine, Sacramento, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. Clark","family":"Brown","sequence":"additional","affiliation":[{"name":"1Department of Pediatrics, Emory University, Atlanta, GA"},{"name":"2Aflac Cancer and Blood Disorders Center, Atlanta, GA"},{"name":"3Children\u2019s Healthcare of Atlanta, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1038-2500","authenticated-orcid":false,"given":"Payal","family":"Desai","sequence":"additional","affiliation":[{"name":"6James Comprehensive Cancer Hospital & Solove Research Institute, The Ohio State University Wexner Medical Center, The Ohio State University, Columbus, OH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8583-0526","authenticated-orcid":false,"given":"Fuad","family":"El Rassi","sequence":"additional","affiliation":[{"name":"7Georgia Comprehensive Sickle Cell Center and Grady Health System, Atlanta, GA"},{"name":"8Department of Medicine, Emory University, Atlanta, GA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beng","family":"Fuh","sequence":"additional","affiliation":[{"name":"9East Carolina University Comprehensive Sickle Cell Center, Greenville, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7002-8891","authenticated-orcid":false,"given":"Julie","family":"Kanter","sequence":"additional","affiliation":[{"name":"10Department of Medicine, University of Alabama, Birmingham, AL"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yves","family":"Pastore","sequence":"additional","affiliation":[{"name":"11CHU Sainte-Justine, Montreal, QC, Canada"},{"name":"12Department of Pediatrics, University of Montreal, Montreal, QC, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1582-2886","authenticated-orcid":false,"given":"Jennifer","family":"Rothman","sequence":"additional","affiliation":[{"name":"13Division of Pediatric Hematology\/Oncology, Duke University Medical Center, Durham, NC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4421-1809","authenticated-orcid":false,"suffix":"VI","given":"James G.","family":"Taylor","sequence":"additional","affiliation":[{"name":"14Center for Sickle Cell Disease, Howard University College of Medicine, Washington, DC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Readett","sequence":"additional","affiliation":[{"name":"15Pfizer Inc, Collegeville, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krupa M.","family":"Sivamurthy","sequence":"additional","affiliation":[{"name":"15Pfizer Inc, Collegeville, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brinda","family":"Tammara","sequence":"additional","affiliation":[{"name":"15Pfizer Inc, Collegeville, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Li-Jung","family":"Tseng","sequence":"additional","affiliation":[{"name":"16Pfizer Inc, New York, NY"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jay Nelson","family":"Lozier","sequence":"additional","affiliation":[{"name":"17GlycoMimetics Inc, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Thackray","sequence":"additional","affiliation":[{"name":"17GlycoMimetics Inc, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John L.","family":"Magnani","sequence":"additional","affiliation":[{"name":"17GlycoMimetics Inc, Rockville, MD"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn L.","family":"Hassell","sequence":"additional","affiliation":[{"name":"18Division of Hematology, University of Colorado, Aurora, CO"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"234","reference":[{"key":"2023082419144841700_bib1","unstructured":"Sickle Cell Disease. 2018. 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