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

TerminatedN/A

Sponsor: Pfizer

Conditions: Sickle Cell Disease

Interventions: Oxbryta® (voxelotor) 500mg Tablets

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 4 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Participants who meet all the following criteria will be eligible for enrollment:

  1. 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
  2. Male or female participants with documented diagnosis of sickle cell disease (all genotypes)
  3. Undergoing treatment with Oxbryta according to the Oxbryta USPI

Exclusion Criteria:

* Participants meeting any of the following criteria will not be eligible for study enrollment:

  1. Current participation in an investigation clinical trial or expanded access program, in which the participant may be receiving voxelotor treatment.
  2. 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

Locations (43)

Mobile, Alabama, United States
Phoenix, Arizona, United States
La Jolla, California, United States
Orange, California, United States
Palo Alto, California, United States
Palo Alto, California, United States
Palo Alto, California, United States
Farmington, Connecticut, United States
Farmington, Connecticut, United States
Wilmington, Delaware, United States
Wilmington, Delaware, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Augusta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
College Park, Maryland, United States
Boston, Massachusetts, United States
Madison, Mississippi, United States
Newark, New Jersey, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Durham, North Carolina, United States
Greenville, North Carolina, United States
Greenville, North Carolina, United States
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