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RECRUITINGPhase 4INTERVENTIONAL

Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 shown to provide benefits for people with SCA. In this research study, the investigators hope to learn more about how to improve the dosing and monitoring of hydroxyurea and learn more about the long-term effects of hydroxyurea over time. Hydroxyurea is usually dosed based only on your weight. Our study will use a new way to select a starting dose that is based on how each patient absorbs hydroxyurea.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Current treatment with regularly scheduled blood transfusions - Sickle-hemoglobin C disease (HbSC), sickle-β+-thalassemia (HbSβ+) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * Current treatment with regularly scheduled blood transfusions * Sickle-hemoglobin C disease (HbSC), sickle-β+-thalassemia (HbSβ+)

Treatments Being Tested

DRUG

PK-optimized oral hydroxyurea at MTD until 15 years of age.

Because people are different, we will measure how each participant's body absorbs and eliminates the medicine, hydroxyurea, using blood tests. This information will be used to determine the best dose for each participant (rather than using the same weight-based dose for everyone).

Locations (1)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States