Retrospective Real World Oxbryta® Data Collection and Analysis Study
NCT ID: NCT04930328
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
216 participants
OBSERVATIONAL
2021-03-20
2022-02-25
Brief Summary
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Detailed Description
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* Clinical outcomes, as assessed by clinical and laboratory assessments of hematological parameters and end organ damage, and incidence of significant clinical events
* Healthcare resource utilization
* Health-related quality of life (HRQoL), as assessed by patient-reported outcome (PRO) measures and clinician-reported outcomes (ClinRO)
The safety objective is to assess the safety and tolerability of Oxbryta.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Retrospective Data Collection
Retrospective Data Collection
Oxbryta® (voxelotor) 500-mg Tablets
Patients will have received treatment with Oxbryta as prescribed by their physician at the approved dose per local prescribing information, as part of their usual care.
Interventions
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Oxbryta® (voxelotor) 500-mg Tablets
Patients will have received treatment with Oxbryta as prescribed by their physician at the approved dose per local prescribing information, as part of their usual care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Willing and able to provide written informed consent (ages greater or equal to 18 years) or parental/guardian consent and patient assent (age \<18 years), as required by the IRB or institution or IRB, per local regulations
2. Male or female patients with documented diagnosis of SCD (all genotypes)
3. Have been treated with Oxbryta for at least 2 weeks, according to the Oxbryta USPI
Exclusion Criteria
0 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 Connecticut Health
Farmington, Connecticut, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Central Michigan University/Children's Hospital of Michigan
Detroit, Michigan, United States
Rutgers Robert Wood Johnson Medical School Pediatric Clinical Research Center
New Brunswick, New Jersey, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Parkland Health & Hospital System
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C5341018
Identifier Type: OTHER
Identifier Source: secondary_id
GBT440-4R1
Identifier Type: -
Identifier Source: org_study_id
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