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Retrospective Real World Oxbryta® Data Collection and Analysis Study
Retrospective Real World Oxbryta® Data Collection and Analysis Study

NCT04930328

CompletedN/A

Sponsor: Pfizer

Conditions: Sickle Cell Disease

Interventions: Oxbryta® (voxelotor) 500-mg Tablets

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 0 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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:

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Locations (12)
  • Farmington, Connecticut, United States
  • Boston, Massachusetts, United States
  • Boston, Massachusetts, United States
  • Detroit, Michigan, United States
  • New Brunswick, New Jersey, United States
  • New Brunswick, New Jersey, United States
  • The Bronx, New York, United States
  • Charlotte, North Carolina, United States
  • Durham, North Carolina, United States
  • Dallas, Texas, United States
  • Dallas, Texas, United States
  • Houston, Texas, United States