Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)
About this study
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.
- Condition
- Sickle Cell Anemia (HbSS), Sickle-β0-thalassemia (HbSβ0)
- Tested
- PK-optimized oral hydroxyurea at MTD until 15 years of age.
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Who can join
- Age
- 0.5 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 5
- Minimum age: 0.5 years
- Study condition: Sickle Cell Anemia (HbSS), Sickle-β0-thalassemia (HbSβ0)
- 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 2
- Current treatment with regularly scheduled blood transfusions
- Sickle-hemoglobin C disease (HbSC), sickle-β+-thalassemia (HbSβ+)
Where
1 site, 1 recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Contact
-
Wendi L. Long, Sr. Regulatory Specialist, BS, CCRC
513-803-3064 wendi.long@cchmc.org
-
Teresa Latham, Research Director, DrPH
(513) 803-7922 teresa.latham@cchmc.org
Potential match only. Final eligibility is determined by the study team.