NCT03789591CompletedPhase 3
Hydroxyurea Optimization Through Precision Study
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.
Source: ClinicalTrials.gov · Last updated 18 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 104 (actual)
- First submitted
- 27 Nov 2018
- Start date
- Jan 2019
- Primary completion date
- Mar 2025
- Lead sponsor
- Lifespan
- Diseases
- Sickle cell disease
- NCT number
- NCT03789591
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 104
- From Jan 2019 to the primary completion date, Mar 2025
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current treatment with chronic, monthly blood transfusions or erythrocytapheresis
- Treatment with hydroxyurea within the past 3 months
- Current treatment with other investigational sickle cell medications
Lab values
- Hemoglobin SC disease, HbS/β+-thalassemia
Other
- Current known pregnancy or lactation
Who the study is looking for
- 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
Age in the registry: 6 months to 21 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Rainbow Babies / University Hospitals Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Riley Hospital for Children at Indiana University Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Indiana Hemophilia & Thrombosis Center, Inc. (IHTC) Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Children's Hospitals and Clinics of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Cohen Children's Medical Center/Northwell Health Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| Children's Hospital of Illinois Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Carle Foundation Hospital Coordinator of this site? Confirm its status | Urbana | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.