Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals With SCD

Stopped early

Conditions studied: Sickle Cell Disease

In brief

This registry is an observational study designed to evaluate the effect of Oxbryta in individuals with SCD in a real-world setting.

Key facts

Study ID

NCT04930445

Run by

Pfizer

People needed

265

Starts

2022-02-04

Expected to finish

2024-10-10

Last updated by the study team

2025-12-31

Who can join

Age: 4 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants who meet all the following criteria will be eligible for enrollment:
• Willing and able to provide written informed consent (aged ≥ 18 years), parental/ guardian consent and participant assent (aged ≥ 12 to <18 years) per local regulations, or pediatric participants (aged 4 to <12 years) with parental/guardian consent per Institutional Review Board (IRB) policy and requirements, consistent with ICH guidelines
• Male or female participants with documented diagnosis of sickle cell disease (all genotypes)
• Undergoing treatment with Oxbryta according to the Oxbryta USPI

You may not qualify if…

• Participants meeting any of the following criteria will not be eligible for study enrollment:
• Current participation in an investigation clinical trial or expanded access program, in which the participant may be receiving voxelotor treatment.
• Medical, psychological, or behavioral condition that, in the opinion of the study doctor, would confound or interfere with evaluation of safety and/or effectiveness of the study drug, prevent compliance with the study protocol; preclude informed consent; or render the participant unable/unlikely to comply with the study procedures

Where it is running

• University of South Alabama — Mobile, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• University of California, San Diego — La Jolla, California, United States
• Center for Inherited Blood Disorders — Orange, California, United States
• Bass Center for Childhood Cancer and Blood Disorders (Stanford Lucile Packard Children's Hospital) — Palo Alto, California, United States
• Department of Pediatrics, Hematology section — Palo Alto, California, United States
• Stanford Children's Hospital — Palo Alto, California, United States
• University of Connecticut Health — Farmington, Connecticut, United States
• University of Connecticut Health — Farmington, Connecticut, United States
• Nemours Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
• Nemours Children's Health, Wilmington — Wilmington, Delaware, United States
• Foundation for Sickle Cell Disease Research — Hollywood, Florida, United States
• Nemours Children's Specialty Care — Jacksonville, Florida, United States
• University of Miami Hospital — Miami, Florida, United States
• Augusta University - Clinical Trials Office (clinic) — Augusta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• University of Illinois at Chicago (UIC) Clinical Research Center — Chicago, Illinois, United States
• University of Illinois at Chicago (UIC) Sickle Cell Center — Chicago, Illinois, United States
• University of Illinois Hospital and Health Sciences System(UI Health) — Chicago, Illinois, United States
• University of Illinois Hospital and Health Sciences System — Chicago, Illinois, United States
• University of Maryland Medical Center — College Park, Maryland, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• Mississippi Center for Advanced Medicine — Madison, Mississippi, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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