CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 216 enrolled
Drug / intervention
Oxbryta® (voxelotor) 500-mg Tabletsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04930328
NCT04930328N/ACompleted

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

Pfizer·observational·Posted Jun 18, 2021·Updated Mar 6, 2024

In Brief

An observational study evaluating Oxbryta® (voxelotor) 500-mg Tablets for Sickle Cell Disease. Completed, enrolled 216 participants across 12 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 18, 2021
Enrollment StartMar 20, 2021
Primary CompletionFeb 25, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 5.0 years ago

Interventions

Oxbryta® (voxelotor) 500-mg Tabletsdrug

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.