Realizing Effectiveness Across Continents With Hydroxyurea

Phase 2

Active, not recruiting

• Conditions: Children; Sickle Cell Disease
• Interventions: Drug: Hydroxyurea

• Registration Number: NCT06171217
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Study Timeline

• Study First Submitted: 2023-08-21
• Study Start: 2023-10-27
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-10-04
• Study Completion: 2033-10-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 810

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Original Cohort	Hydroxyurea	The original REACH cohort continuing study treatment per the protocol schedule of evaluations.
New Cohort	Hydroxyurea	Newly enrolled REACH participants consent, 3 months screening, and treatment per the protocol schedule of evaluations

Primary Outcome Measures

Name	Time	Method
Efficacy of long-term Hydroxyurea treatment at MTD	Assessed every 6 ± 1 months up to 204 months	The efficacy of hydroxyurea will be primarily assessed through fetal hemoglobin (HbF), comparing treatment with baseline values.

Secondary Outcome Measures

Name	Time	Method
Success of PK-guided dosing of hydroxyurea	Assessed every 6 ± 1 months up to 204 months	Fetal Hemoglobin changes from hydroxyurea at MTD
Reduction of malaria incidents while on hydroxyurea at MTD.	Assessed every 4 ± 1 weeks, then every 3 ± 1months up to 204 months	Clinical malaria infections to identify associations of risk or protection comparing treated and untreated incidents.

Trial Locations

Locations (4)

Hospital Pediátrico David Bernardino; 🇦🇴 Luanda, Angola

Centre Hospitalier Monkole; 🇨🇩 Kinshasa, Congo, The Democratic Republic of the

KEMRI/Wellcome Trust Research; 🇰🇪 Kilifi, Kenya

Mbale Regional Hospital; 🇺🇬 Mbale, Uganda