Realizing Effectiveness Across Continents With Hydroxyurea (NCT06171217) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Realizing Effectiveness Across Continents With Hydroxyurea
Angola, Democratic Republic of the Congo, Kenya811 participantsStarted 2023-10-27
Plain-language 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.
Who can participate
Age range3 Years – 10 Years
SexALL
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Inclusion criteria
✓. Pediatric patients with documented sickle cell anemia (typically HbSS supported by hemoglobin electrophoresis, complete blood count, and peripheral blood smear)
✓. In the Original Cohort, age range of 1.00-9.99 years, inclusive, at the time of enrollment (now age 5.5 - 17.5 years); age range 3.0-10.0 years for the New Cohort
✓. Weight at least 10.0 kg at the time of enrollment
✓. Parent or guardian willing and able to provide written informed consent, with child's verbal assent as per local IRB/Ethics Board requirements
✓. Willingness to comply with all study-related treatments, evaluations, and follow-up
Exclusion criteria
✕. Known medical condition making participation ill-advised (e.g., acute or chronic infectious disease, HIV, or malignancy)
✕. Acute or chronic severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age \>3 z-scores below the median WHO growth standards.
✕
What they're measuring
1
Efficacy of long-term Hydroxyurea treatment at MTD
Timeframe: Assessed every 6 ± 1 months up to 204 months
Trial details
NCT IDNCT06171217
SponsorChildren's Hospital Medical Center, Cincinnati