Retrospective Real World Oxbryta® Data Collection and Analysis Study
Completed
Conditions studied: Sickle Cell Disease
In brief
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.
Key facts
- Study ID
- NCT04930328
- Run by
- Pfizer
- People needed
- 216
- Starts
- 2021-03-20
- Expected to finish
- 2022-02-25
- Last updated by the study team
- 2024-03-06
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who meet all the following criteria will be eligible for inclusion in this study:
- 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
- Male or female patients with documented diagnosis of SCD (all genotypes)
- Have been treated with Oxbryta for at least 2 weeks, according to the Oxbryta USPI
Where it is running
- University of Connecticut Health — Farmington, Connecticut, United States
- Brigham and Women's Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Central Michigan University/Children's Hospital of Michigan — Detroit, Michigan, United States
- Rutgers Robert Wood Johnson Medical School Pediatric Clinical Research Center — New Brunswick, New Jersey, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Parkland Health & Hospital System — Dallas, Texas, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
- University of Texas Health Science Center at Houston — Houston, Texas, United States
Full record on ClinicalTrials.gov
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