Clinical Trial
Study Details
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.
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.
Study Overview
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.
Contacts and Locations
University of Connecticut Health
Farmington, Connecticut 06030
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Central Michigan University/Children's Hospital of Michigan
Detroit, Michigan 48201
United States
Rutgers Robert Wood Johnson Medical School Pediatric Clinical Research Center
New Brunswick, New Jersey 08901
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903-2681
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Levine Cancer Institute
Charlotte, North Carolina 28204
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Parkland Health & Hospital System
Dallas, Texas 75235
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
University of Texas Health Science Center at Houston
Houston, Texas 77030
United States