Status:
RECRUITING
Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
Greater Cincinnati Foundation
Conditions:
Sickle Cell Anemia (HbSS)
Sickle-β0-thalassemia (HbSβ0)
Eligibility:
All Genders
6+ years
Phase:
PHASE4
Brief Summary
The main reason for this research study is to learn more about hydroxyurea and the treatment of sickle cell anemia (SCA). Hydroxyurea is a medication that has been studied for many years and has been ...
Detailed Description
The EHANCE study will address key knowledge gaps about hydroxyurea for young children with SCA in nine innovative ways: * Novel functional assessments of brain, heart, kidneys, spleen, and eyes to as...
Eligibility Criteria
Inclusion
- Diagnosis of sickle cell anemia (HbSS) or sickle-β0-thalassemia (HbSβ0)
- Age 6 months at the time of enrollment
- Clinical decision by patient, family, and healthcare provider to initiate hydroxyurea therapy
Exclusion
- Current treatment with regularly scheduled blood transfusions
- Sickle-hemoglobin C disease (HbSC), sickle-β+-thalassemia (HbSβ+)
Key Trial Info
Start Date :
December 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07177300
Start Date
December 19 2024
End Date
December 1 2028
Last Update
September 16 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229