Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center, randomized trial that will directly compare a novel, individualized dosing strategy of hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of the study is to evaluate whether a pharmacokinetics-based starting hydroxyurea dose thieves superior fetal hemoglobin response to to standard weight-based initial dosing. Patients will be recruited from the pediatric sickle cell clinic at Cincinnati Children’s Hospital Medical Center and from additional pediatric sickle cell centers within the United States.
| Patrick McGann, MD | |
| 513-736-2246 | |
| [email protected] |
6 Months - 21 Years
Phase 3
Interventional
All
Drug
Diagnosis of sickle cell anemia (HbSS, HbSD, HbS/β0-thalassemia, or similarly severe SCA genotype)
Age 6 months to 21 years at the time of enrollment
Clinical decision by patient, family, and healthcare providers to initiate hydroxyurea therapy
Current treatment with chronic, monthly blood transfusions or erythrocytapheresis
Treatment with hydroxyurea within the past 3 months
Hemoglobin SC disease, HbS/β+-thalassemia
Current treatment with other investigational sickle cell medications
Current known pregnancy or lactation