drugset / Trial / NCT06171217
Realizing Effectiveness Across Continents With Hydroxyurea
Phase 2
Active not recruiting
811 enrolled
Children's Hospital Medical Center, Cincinnati
National Heart, Lung, and Blood Institute (NHLBI) · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for children with confirmed SCA between 3 and 10 years of age. The short-term goal is to obtain critical pilot data regarding the feasibility, safety, and benefit of hydroxyurea for children with SCA in multiple distinct research settings in Africa. Based on that information, the longer-term goal is to make hydroxyurea more widely available for children with SCA in Africa, particularly those identified with SCA through expanded newborn screening programs.
Timeline
- Start
- 2023-10-27
- Primary completion
- 2027-10-04
- Completion
- 2033-10-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Hydroxyurea | Other / unclassified | 15 mg/kg | — |
| Subject | Hydroxyurea | Other / unclassified | 20 mg/kg | — |
| Subject | Hydroxyurea | Other / unclassified | 30 mg/kg | — |
| Subject | Hydroxyurea | Other / unclassified | 35 mg/kg | — |