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Voxelotor Only Product in Oral Dose Form for Sickle Cell Disease

Phase 3

Waitlist Available

Research Sponsored by Global Blood Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of study treatment (day 1) up to week 12

Awards & highlights

Study Summary

This trial will test if voxelotor can improve neurocognitive function in children with sickle cell disease.

Eligible Conditions

Sickle Cell Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of study treatment (day 1) up to week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of study treatment (day 1) up to week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study treatment (day 1) up to week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Executive Abilities Composite Score Assessed Using NIH Toolbox Cognition Module At Week 12

Secondary outcome measures

Change From Baseline in Absolute Reticulocyte Count Up to Week 12

Change From Baseline in Hemoglobin Level Up to Week 12

Change From Baseline in Lactate Dehydrogenase (LDH) Up to Week 12

+5 more

Other outcome measures

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Active DrugExperimental Treatment1 Intervention

Voxelotor 1500mg or equivalent daily as a tablet or powder for oral suspension

Group II: PlaceboPlacebo Group1 Intervention

Matching Placebo

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Who is running the clinical trial?

Global Blood TherapeuticsLead Sponsor

35 Previous Clinical Trials

4,876 Total Patients Enrolled

PfizerLead Sponsor

4,578 Previous Clinical Trials

10,923,801 Total Patients Enrolled

Pfizer CT.gov Call CenterStudy DirectorPfizer

3,484 Previous Clinical Trials

8,099,868 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the patients in this trial required to be of age?

"This research project is only enrolling participants that are children aged 8-17. Out of the over 200 clinical trials currently underway, 133 involve minors and 86 involve patients over 65 years old."

Answered by AI

Is Voxelotor the only FDA-approved oral medication?

"This medication, which is taken orally in the form of a pill, received a safety rating of 3. This reflects that there have been multiple rounds of testing supporting Voxelotor's safety as well as some evidence of efficacy."

Answered by AI

To whom does this clinical trial grant admission?

"This particular medical trial is testing a new intervention for patients with anemia and sickle cell that are between the ages of 8 and 17. They are looking to enroll around 80 children in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Voxelotor Neurocognitive Function Study

2022. "Voxelotor Neurocognitive Function Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05228834.