The aim of this study is to collect and analyze retrospective data on Oxbryta in a real-world setting. This is a multicenter, retrospective data collection and analysis study to characterize health outcomes in approximately 300 patients with SCD who have been treated with Oxbryta as part of their usual care. Any patient with SCD who received Oxbryta treatment for at least 2 weeks as part of their usual care according to the Oxbryta US Prescribing Information (USPI) is eligible to participate. Study data from 1 year before and up to 1 year after the first dose of Oxbryta will be entered in case report forms (CRFs) via an electronic data capture (EDC) system by the study staff.
The following are categories of interest in patients with SCD treated with Oxbryta: * Clinical outcomes, as assessed by clinical and laboratory assessments of hematological parameters and end organ damage, and incidence of significant clinical events * Healthcare resource utilization * Health-related quality of life (HRQoL), as assessed by patient-reported outcome (PRO) measures and clinician-reported outcomes (ClinRO) The safety objective is to assess the safety and tolerability of Oxbryta.
Study Type
OBSERVATIONAL
Enrollment
216
Patients will have received treatment with Oxbryta as prescribed by their physician at the approved dose per local prescribing information, as part of their usual care.
University of Connecticut Health
Farmington, Connecticut, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Central Michigan University/Children's Hospital of Michigan
Detroit, Michigan, United States
Rutgers Robert Wood Johnson Medical School Pediatric Clinical Research Center
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Parkland Health & Hospital System
Dallas, Texas, United States
...and 2 more locations
Change from pre-Oxbryta treatment period in Hemoglobin (Hb)
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Change from pre-Oxbryta treatment period in percent Reticulocytes
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Change from pre-Oxbryta treatment period in Absolute Reticulocytes
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Change from pre-Oxbryta treatment period in Bilirubin
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Incidence of significant SCD-related clinical events
Such as vaso-occlusive crisis (VOC), acute chest syndrome (ACS), priapism, cerebral infarcts, transient ischemic attack (TIA), leg ulcers, and measures of cardiac function and pulmonary hypertension (PH)
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Change from pre-Oxbryta treatment period in incidence of unplanned clinic visits
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Change from pre-Oxbryta treatment period in incidence of emergency department (ED) visits
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Change from pre-Oxbryta treatment period in incidence of hospitalizations (including total length of stay and time in intensive care unit [ICU], if applicable)
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Change from pre-Oxbryta treatment period in incidence of red blood cell transfusions
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Incidence and severity of serious adverse events (SAEs)
Time frame: 1 year before and 1 year after the first dose of Oxbryta
Incidence and severity of adverse events (AEs) of interest
Such as Rash, Diarrhea, Headache, AEs leading to Oxbryta dose modification or discontinuation
Time frame: 1 year before and 1 year after the first dose of Oxbryta
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