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Hemoglobin S Polymerization Inhibitor

Retrospective Data Collection for Sickle Cell Disease (RETRO Trial)

N/A
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year before and 1 year after the first dose of oxbryta
Awards & highlights

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.

Eligible Conditions
  • Sickle Cell Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year before and 1 year after the first dose of oxbryta
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year before and 1 year after the first dose of oxbryta for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence and severity of adverse events (AEs) of interest
Incidence of significant SCD-related clinical events

Trial Design

1Treatment groups
Experimental Treatment
Group I: Retrospective Data CollectionExperimental Treatment1 Intervention
Retrospective Data Collection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxbryta® (voxelotor) 500-mg Tablets
2021
N/A
~220

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,625 Previous Clinical Trials
14,283,978 Total Patients Enrolled
Global Blood TherapeuticsLead Sponsor
35 Previous Clinical Trials
4,267 Total Patients Enrolled
David Purdie, PhDStudy DirectorGlobal Blood Therapeutics, Inc.
1 Previous Clinical Trials
1,000 Total Patients Enrolled
~49 spots leftby Sep 2025
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