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NCT02556099Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2014
- Primary completion
- Jan 2023
- Countries
- 1
- Sponsor
- Cincinnati Children's Hospital Medical Center
- Modality
- Small Molecules
- Drugs
- hydroxyurea
- Conditions
- sickle cell anemia (SCA)
01
Overview
Phase 2, open-label, single-arm trial of hydroxyurea in sickle cell anemia (SCA), sponsored by Cincinnati Children's Hospital Medical Center. Primary endpoint: Maximum Time-Averaged Mean velocity on TCD exam at 18 months. Started Aug 2014; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Hydroxyurea Treatment
Hydroxyurea administered once daily by mouth, escalated to MTD.
03
Who it enrols
Pediatric patients (2-17 years) with severe sickle cell anemia and conditional or abnormal TCD velocities, without recent use of other SCD therapeutic agents or severe baseline cytopenias.
04
Endpoints
Primary
Maximum Time-Averaged Mean velocity on TCD exam
Secondary
Serial Transcranial Doppler velocities
Cumulative incidence of neurological events
Cumulative Incidence of Non-Neurological Events
Quality of Life Assessment
Neuropsychological Assessment
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