Status:
RECRUITING
Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Novartis
Conditions:
Sickle Cell Anemia in Children
Sickle Cell Disease
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
The Promoting Utilization and Safety of Hydroxyurea Using Precision in Africa (PUSHUP) trial is a prospective, randomized clinical trial of hydroxyurea for 400 children with SCA in Luanda, Angola. The...
Eligibility Criteria
Inclusion
- 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 ≥ 7.5 kg (temporary exclusion)
Exclusion
- 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)
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05285917
Start Date
November 15 2023
End Date
September 1 2027
Last Update
April 9 2025
Active Locations (1)
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1
Hospital Geral dos Cajueiros
Luanda, Angola