Hydroxyurea Optimization Through Precision Study
Completed · Phase 3
Conditions studied: Sickle Cell Disease, Sickle Cell Anemia
In brief
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.
Key facts
- Study ID
- NCT03789591
- Run by
- Lifespan
- People needed
- 104
- Starts
- 2019-01-17
- Expected to finish
- 2025-03-19
- Last updated by the study team
- 2025-06-18
Who can join
Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Children's Hospital of Illinois — Peoria, Illinois, United States
- Carle Foundation Hospital — Urbana, Illinois, United States
- Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States
- Indiana Hemophilia & Thrombosis Center, Inc. (IHTC) — Indianapolis, Indiana, United States
- Boston Children's Hospital — Boston, Massachusetts, United States
- Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
- Cohen Children's Medical Center/Northwell Health — New Hyde Park, New York, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Rainbow Babies / University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
- Nationwide Children's Hospital. — Columbus, Ohio, United States
- Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
- Phoenix Children's Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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