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Investigators from multiple institutions conducted an open-label trial to assess the feasibility, safety, and clinical benefits of hydroxyurea in children with sickle cell anemia (SCA) in sub-Saharan Africa. Children were eligible if they were aged 1–10 years and received care for SCA at 1 of 4 study hospitals in Angola, Democratic Republic of the Congo, Kenya, and Uganda.
Participants first completed a 2-month pretrial phase that included a history and physical, complete blood cell count, and malaria assessment. Participants then entered the treatment phase, which involved starting hydroxyurea at 15–20 mg/kg for 6 months followed by a 6-month dose escalation phase and a 24-month maintenance phase. The escalation phase involved increasing the hydroxyurea dose by 2.5 to 5.0 mg/kg/day every 2 …
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