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NCT04930445Terminated

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

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

Source: ClinicalTrials.gov · Last updated 31 Dec 2025

Reason given: Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research, and requires further assessment.

Brief summary (registry, in English)

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

Status (registry)
Terminated
Study type
Observational
Enrollment
265 (actual)
First submitted
4 Jun 2021
Start date
4 Feb 2022
Primary completion date
10 Oct 2024
Lead sponsor
Pfizer
NCT number
NCT04930445

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Who the study is looking for

  • 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

Age in the registry: 4 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (42)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Augusta University - Clinical Trials Office (clinic)AugustaUnited StatesUnknown status
Augusta UniversityAugustaUnited StatesUnknown status
Children's Blood and Cancer Center at Dell Children's Medical CenterAustinUnited StatesUnknown status
Dell Children's Medical CenterAustinUnited StatesUnknown status
Boston University Medical CenterBostonUnited StatesUnknown status
Medical University of South CarolinaCharlestonUnited StatesUnknown status
Medical University of South Carolina: Shawn Jenkins Women's and Children's HospitalCharlestonUnited StatesUnknown status
Levine Cancer InstituteCharlotteUnited StatesUnknown status
University of Illinois at Chicago (UIC) Sickle Cell CenterChicagoUnited StatesUnknown status
University of Illinois Hospital and Health Sciences SystemChicagoUnited StatesUnknown status
University of Illinois Hospital and Health Sciences System(UI Health)ChicagoUnited StatesUnknown status
University of Illinois at Chicago (UIC) Clinical Research CenterChicagoUnited StatesUnknown status
University of Maryland Medical CenterCollege ParkUnited StatesUnknown status
Duke University HospitalDurhamUnited StatesUnknown status
Duke University Medical CenterDurhamUnited StatesUnknown status
Inova Schar Cancer InstituteFairfaxUnited StatesUnknown status
Inova HealthFalls ChurchUnited StatesUnknown status
University of Connecticut HealthFarmingtonUnited StatesUnknown status
ECU Health Medical Center LaboratoryGreenvilleUnited StatesUnknown status
ECU Health Medical CenterGreenvilleUnited StatesUnknown status
East Carolina UniversityGreenvilleUnited StatesUnknown status
Foundation for Sickle Cell Disease ResearchHollywoodUnited StatesUnknown status
University of Texas Health Science Center at HoustonHoustonUnited StatesUnknown status
Nemours Children's Specialty CareJacksonvilleUnited StatesUnknown status
University of California San DiegoLa JollaUnited StatesUnknown status
Mississippi Center for Advanced MedicineMadisonUnited StatesUnknown status
St. Jude Children's Research HospitalMemphisUnited StatesUnknown status
University of Miami HospitalMiamiUnited StatesUnknown status
University of South AlabamaMobileUnited StatesUnknown status
Newark Beth Israel Medical CenterNewarkUnited StatesUnknown status
Center for Inherited Blood DisordersOrangeUnited StatesUnknown status
Bass Center for Childhood Cancer and Blood Disorders (Stanford Lucile Packard Children's Hospital)Palo AltoUnited StatesUnknown status
Department of Pediatrics, Hematology sectionPalo AltoUnited StatesUnknown status
Stanford Children's HospitalPalo AltoUnited StatesUnknown status
Phoenix Children s HospitalPhoenixUnited StatesUnknown status
UPMC Sickle Cell CenterPittsburghUnited StatesUnknown status
UPMC Montefiore HospitalPittsburghUnited StatesUnknown status
UPMC PresbyterianPittsburghUnited StatesUnknown status
University of Pittsburgh Medical Center (UPMC)PittsburghUnited StatesUnknown status
Montefiore Medical CenterThe BronxUnited StatesUnknown status
Nemours Children's Health, WilmingtonWilmingtonUnited StatesUnknown status
Nemours/Alfred I. duPont Hospital for ChildrenWilmingtonUnited StatesUnknown status

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Related publications

This page is information, not medical advice. Discuss any trial with your doctor.