Oxbryta® Product Registry An Observational Study Designed to Evaluate the Effect of Oxbryta in Individuals With SCD
NCT ID: NCT04930445
Last Updated: 2025-12-31
Study Results
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View full resultsBasic Information
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TERMINATED
265 participants
OBSERVATIONAL
2022-02-04
2024-10-10
Brief Summary
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Detailed Description
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This registry is an observational study to evaluate the effects of Oxbryta in individuals with SCD. Any participant who is currently taking Oxbryta, or has been prescribed and will initiate treatment with Oxbryta, is eligible to participate. Eligible participants will receive treatment with Oxbryta as prescribed by their physician, as part of their usual care. Participants will be treated and evaluated per standard of care (SOC) and at the physician's discretion. This study will collect data that are recorded in the participants' medical records and other secondary data sources. Study data will be collected at regular intervals and entered in case report forms (CRFs) via an electronic data capture (EDC) system by the study staff. Participants will be considered to be on study for up to 5 years after their first dose of Oxbryta treatment, or until they withdraw their consent to participate, or are discontinued from the study. Treatment, including interruptions and restarting treatment, will continue at the discretion of the treating physician, and there are no pre-defined treatment requirements. Participants may receive any additional medications prescribed by their treating physician, or have any medical interventions that are deemed appropriate by the treating physician or study doctor. The participant or treating physician may discontinue Oxbryta at any time. Participants who discontinue treatment with Oxbryta earlier than 5 years will continue to be followed on study to collect clinical and quality of life (QoL) outcomes for up to 5 years after their first dose of Oxbryta treatment. Participant safety and tolerability will be assessed throughout the study data collection period by the study doctor and reported to the Sponsor.
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Oxbryta Product Registry
Oxbryta® (voxelotor) 500mg Tablets
Participants will receive treatment with Oxbryta as prescribed by their physician, as part of their usual care. Participants will be treated and evaluated per standard of care (SOC) and at the physician's discretion. There are no pre-defined treatment requirements.
Interventions
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Oxbryta® (voxelotor) 500mg Tablets
Participants will receive treatment with Oxbryta as prescribed by their physician, as part of their usual care. Participants will be treated and evaluated per standard of care (SOC) and at the physician's discretion. There are no pre-defined treatment requirements.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
4 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Hospital
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
ECU Health Medical Center Laboratory
Greenville, North Carolina, United States
ECU Health Medical Center
Greenville, North Carolina, United States
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, United States
UPMC Sickle Cell Center
Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center (UPMC)
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Shawn Jenkins Women's and Children's Hospital
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Children's Blood and Cancer Center at Dell Children's Medical Center
Austin, Texas, United States
Dell Children's Medical Center
Austin, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
INOVA Health
Falls Church, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5341019
Identifier Type: OTHER
Identifier Source: secondary_id
GBT440-4R2
Identifier Type: -
Identifier Source: org_study_id