Tests a personalized hydroxyurea dose for children with sickle cell disease
Tests hydroxyurea dosed to each child's absorption in sickle cell anemia.
Key facts
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Where
- Cincinnati, United StatesSee the site
- Trial code
- Registry title
- Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 50 people, planned
- Started
- 19 Dec 2024
- Expected to end
- Dec 2028
- Type of study
- Interventional
- Treatments tested
- PK-optimized oral hydroxyurea at MTD until 15 years of age.
- Record updated
- 16 September 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with sickle cell anemia (HbSS or HbSβ0) who, with their family and doctor, have decided to start hydroxyurea.
- Age
- 6 months or older
- Sex
- All sexes can join.
- Disease stage
- Sickle cell anemia (HbSS) or sickle-β0-thalassemia (HbSβ0).
- Earlier treatment
- People who get regularly scheduled blood transfusions now cannot join.
Main reasons for not taking part
- Current treatment with regularly scheduled blood transfusions
- Sickle-hemoglobin C disease (HbSC)
- Sickle-β+-thalassemia (HbSβ+)
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Diagnosis of sickle cell anemia (HbSS) or sickle-β0-thalassemia (HbSβ0)
- Age 6 months at the time of enrollment
- Clinical decision by patient, family, and healthcare provider to initiate hydroxyurea therapy
Who cannot take part
- Current treatment with regularly scheduled blood transfusions
- Sickle-hemoglobin C disease (HbSC), sickle-β+-thalassemia (HbSβ+)
Where in United States
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesContact: Charles T. Quinn, M.D., M.S.Taking people
About the trial
What the trial wants to find out
The main reason for this research study is to learn more about hydroxyurea and the treatment of sickle cell anemia (SCA). Hydroxyurea is a medication that has been studied for many years and has been shown to provide benefits for people with SCA.
Read full original descriptionShow less
In this research study, the investigators hope to learn more about how to improve the dosing and monitoring of hydroxyurea and learn more about the long-term effects of hydroxyurea over time. Hydroxyurea is usually dosed based only on your weight. Our study will use a new way to select a starting dose that is based on how each patient absorbs hydroxyurea.
The group in the trial
- Observational Treatment Group (Single Arm)Treatment being tested
All children with sickle cell anemia who are started on hydroxyurea for clinical indicators between 6 months and 5 years of age can do so on this observational study with PK-optimized hydroxyurea dosing.
Treatment: PK-optimized oral hydroxyurea at MTD until 15 years of age.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)
- Plain-language title
- Tests a personalized hydroxyurea dose for children with sickle cell diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 16 September 2025