Hydroxyurea Optimization Through Precision Study

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Doris Duke Charitable Foundation
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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