Retrospective Real World Oxbryta® Data Collection and Analysis Study (RETRO)

Pfizer

Status: Completed

Conditions: Sickle Cell Disease

Treatments: Drug: Oxbryta® (voxelotor) 500-mg Tablets

Study type: Observational

Funder types: Industry

Identifiers

NCT04930328

C5341018 (Other Identifier)

GBT440-4R1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

216 participants in 1 patient group

Retrospective Data Collection

Description:

Retrospective Data Collection

Treatment:

Drug: Oxbryta® (voxelotor) 500-mg Tablets