Voxelotor Brain Oxygenation and Neurocognitive Study
NCT05228821 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2024-08-09
Summary
This is an open label, single arm multicenter trial to evaluate the effect of voxelotor treatment on cerebral blood flow (CBF) and neurocognitive function in adolescent and young adult participants (12-30 years of age) with sickle cell disease (SCD).
Conditions
Interventions
- DRUG
-
Voxelotor Oral Tablet
During the Treatment Period, participants will receive 1500 mg of voxelotor once daily (administered as tablets) for 24 weeks in addition to ongoing current standard of care (SOC) treatment
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-09
- Primary Completion
- 2023-08-23
- Completion
- 2023-08-23
- FDA Drug
- Yes
Countries
- United States
Study Locations
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