drugset / Trial / NCT06171217

Realizing Effectiveness Across Continents With Hydroxyurea

NCT06171217

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

EvaluationDrugModalityDoseRoute
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

Indications