drugset / Trial / NCT03789591

Hydroxyurea Optimization Through Precision Study

NCT03789591

Phase 3 Completed 104 enrolled Lifespan Doris Duke Charitable Foundation · collab
RandomizedParallel-groupTriple-blindPrevention

Summary

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.

Timeline

Start
2019-01-17
Primary completion
2025-03-19
Completion
2025-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydroxyurea Other / unclassified 20 mg/kg Oral

Indications