An Open Label, Observational, Prospective Registry of Participants With Sickle Cell Disease (SCD) Treated With Oxbryta® (Voxelotor)

About the study

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

Study point of contact

Michelle Xu, MD
650-534-2574
[email protected]
Eleanor Sales
esale[email protected]

Locations

4 United States sites

Age

Years

Study type

Observational [Patient Registry]

Gender

All

Interventions

Drug

participation requirements

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

participation restrictions

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

Locations

  • Bronx, New York, United States, Montefiore Medical Center
  • Charlotte, North Carolina, United States, Levine Cancer Institute - Atrium Health
  • Durham, North Carolina, United States, Duke University Hospital
  • Greenville, North Carolina, United States, East Carolina University - Brody School of Medicine
Last updated 2022-03-10