Hydroxyurea Optimization Through Precision Study (HOPS): A Prospective, Multi-center, Randomized Trial of Personalized, Pharmacokinetics-guided Dosing of Hydroxyurea Versus Standard Weight-based Dosing for Children With Sickle Cell Anemia.

About the study

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.

Study point of contact

Patrick McGann, MD
513-736-2246
[email protected]
Amanda Pfeiffer
513-803-4977
[email protected]

Age

6 Months - 21 Years

Genotypes

HbSS, SCA

Phase

Phase 3

Study type

Interventional

Gender

All

Interventions

Drug

participation requirements

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

participation restrictions

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

Last updated 2021-12-07