Status:
COMPLETED
Hydroxyurea Optimization Through Precision Study
Lead Sponsor:
Lifespan
Collaborating Sponsors:
Doris Duke Charitable Foundation
Conditions:
Sickle Cell Disease
Sickle Cell Anemia
Eligibility:
All Genders
6-21 years
Phase:
PHASE3
Brief 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 w...
Detailed Description
The trial will recruit patients who have decided to initiate hydroxyurea therapy. All participants will have pharmacokinetics studies performed at baseline, following a 20 mg/kg oral dose of hydroxyur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT03789591
Start Date
January 17 2019
End Date
March 19 2025
Last Update
June 18 2025
Active Locations (13)
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1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
3
Children's Hospital of Illinois
Peoria, Illinois, United States, 61637
4
Carle Foundation Hospital
Urbana, Illinois, United States, 61801