drugset / Trial / NCT01531387
Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE)
Phase 3
Terminated
38 enrolled
Children's Hospital Medical Center, Cincinnati
Instituto Estadual de Hematologia Arthur de Siqueira Cavalcanti · collabNational Heart, Lung, and Blood Institute (NHLBI) · collabSt. Jude Children's Research Hospital · collabTropical Medicine Research Institute · collab
RandomizedParallel-groupOpen-labelPrevention
Summary
The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.
Timeline
- Start
- 2012-05
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyurea | Other / unclassified | 20 mg/kg | Oral |
| Subject | Hydroxyurea | Other / unclassified | 300 mg | Oral |
| Subject | Hydroxyurea | Other / unclassified | 400 mg | Oral |
| Subject | Hydroxyurea | Other / unclassified | 500 mg | Oral |