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โ† Trials
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Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa

RecruitingPhase 3Ages 6 Months - 12 YearsAllBrown University
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In plain words

What the trial is, and whether it could suit you

Sickle cell anemia (SCA) is among the world's most common and devastating blood disorders, affecting more than 300,000 newborns per year. Most infants with SCA are born in the low-resource settings of sub- Saharan Africa, where an estimated 50-90% will die before 5 years of age due to lack of early diagnosis and appropriate care. Hydroxyurea is a safe and effective once-daily oral medication that has become the standard of care for the treatment of children with SCA in high-resource settings. There is now a growing body of evidence to support the safety and clinical benefits of hydroxyurea for the treatment of SCA in sub-Saharan Africa. The requirement for frequent laboratory monitoring, uncertainties about appropriate, most effective dosing, and the concern for hematologic laboratory toxicities, however, will continue to limit widespread hydroxyurea utilization and real-world effectiven

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of sickle cell anemia (HbSS or HbS/B0-thalassemia) * Age 6 months- 12 years of age at enrollment * Parent or guardian willing and able to provide written or informed consent * Weight โ‰ฅ 7.5 kg (temporary exclusion) Exclusion Criteria: * Splenomegaly with evidence of hypersplenism as defined by platelet count \<150,000, hemoglobin \<5 g/dL or absolute neutrophil count \<1.0 x10\^9/L * Hydroxyurea use within the past 6 months * Blood transfusion within the past 6 months (temporary exclusion) * Pregnancy * Pre-existing severe hematologic toxicity, as defined by platelet count \<80,000, hemoglobin \<4 regardless of ANC; hemoglobin \<6 AND ARC \<100; hemoglobin \<7 AND ARC \<80 x10\^9/L (temporary exclusion)
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What it tests

  • Hydroxyurea
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Where

1 site
Hospital Geral dos Cajueiros
Luanda, Angola
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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