NCT06171217

Realizing Effectiveness Across Continents With Hydroxyurea

Realizing Effectiveness Across Continents With Hydroxyurea: A Phase I/II Prospective Trial of Hydroxyurea for Children With Sickle Cell Anemia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 810 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 3 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. In the REACH prospective trial, the Original Cohort will receive long-term treatment while for the New Cohort, treatment will continue at least 4 years using PK-guided dosing after an initial 3-month screening period.

Conditions

• Sickle Cell Disease
• Children

Interventions

Type	Name	Description
DRUG	Hydroxyurea	Hydroxyurea, approximately 20-30 mg/kg/day, with modifications for toxicity or for mild marrow suppression
DRUG	Hydroxyurea	Hydroxyurea 15-35 mg/kg/day based on PK-guided dosing, with modifications for toxicity for mild marrow suppression

Timeline

• Start date: 2023-10-27
• Primary completion: 2027-10-04
• Completion: 2033-10-04
• First posted: 2023-12-14
• Last updated: 2025-05-14

Locations

4 sites across 4 countries: Angola, Democratic Republic of the Congo, Kenya, Uganda