A Retrospective Data Collection and Analysis Study of Patients With Sickle Cell Disease (SCD) Who Have Been Treated With Oxbryta® (Voxelotor)

Status: Completed
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The aim of this study is to collect and analyze retrospective data on Oxbryta in a real-world setting. This is a multicenter, retrospective data collection and analysis study to characterize health outcomes in approximately 300 patients with SCD who have been treated with Oxbryta as part of their usual care. Any patient with SCD who received Oxbryta treatment for at least 2 weeks as part of their usual care according to the Oxbryta US Prescribing Information (USPI) is eligible to participate. Study data from 1 year before and up to 1 year after the first dose of Oxbryta will be entered in case report forms (CRFs) via an electronic data capture (EDC) system by the study staff.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

⁃ Patients who meet all the following criteria will be eligible for inclusion in this study:

• 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

• Male or female patients with documented diagnosis of SCD (all genotypes)

• Have been treated with Oxbryta for at least 2 weeks, according to the Oxbryta USPI

Locations
United States
Connecticut
University of Connecticut Health
Farmington
Massachusetts
Brigham and Women's Hospital
Boston
Dana-Farber Cancer Institute
Boston
Michigan
Central Michigan University/Children's Hospital of Michigan
Detroit
North Carolina
Levine Cancer Institute
Charlotte
Duke University Medical Center
Durham
New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick
Rutgers Robert Wood Johnson Medical School Pediatric Clinical Research Center
New Brunswick
New York
Montefiore Medical Center
Bronx
Texas
Parkland Health & Hospital System
Dallas
UT Southwestern Medical Center
Dallas
University of Texas Health Science Center at Houston
Houston
Time Frame
Start Date: 2021-03-20
Completion Date: 2022-02-25
Participants
Target number of participants: 216
Treatments
Retrospective Data Collection
Retrospective Data Collection
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov