Purpose

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.

Condition

Eligibility

Eligible Ages
Over 0 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

Patients who meet all the following criteria will be eligible for inclusion in this study: 1. Willing and able to provide written informed consent (ages greater or equal to 18 years) or parental/guardian consent and patient assent (age <18 years), as required by the IRB or institution or IRB, per local regulations 2. Male or female patients with documented diagnosis of SCD (all genotypes) 3. Have been treated with Oxbryta for at least 2 weeks, according to the Oxbryta USPI

Exclusion Criteria

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Retrospective Data Collection Retrospective Data Collection
  • 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.
    Other names:
    • Voxelotor
    • Oxbryta®

More Details

Status
Completed
Sponsor
Pfizer

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.