drugset / Trial / NCT01966731

Realizing Effectiveness Across Continents With Hydroxyurea (REACH)

NCT01966731

Phase 1/2 Active not recruiting 635 enrolled Children's Hospital Medical Center, Cincinnati
Non-randomizedSingle-groupOpen-labelTreatment

Summary

REACH is a prospective, phase I/II open-label dose escalation trial of hydroxyurea for for pediatric patients with sickle cell anemia (SCA). 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
2014-06
Primary completion
2018-07-01
Completion
2033-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxyurea Other / unclassified 20 mg/kg Oral
Subject Hydroxyurea Other / unclassified 30 mg/kg Oral

Indications