NCT04930328

Retrospective Real World Oxbryta® Data Collection and Analysis Study

A Retrospective Data Collection and Analysis Study of Patients With Sickle Cell Disease (SCD) Who Have Been Treated With Oxbryta® (Voxelotor)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 216 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	Oxbryta® (voxelotor) 500-mg Tablets	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.

Timeline

• Start date: 2021-03-20
• Primary completion: 2022-02-25
• Completion: 2022-02-25
• First posted: 2021-06-18
• Last updated: 2024-03-06

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study