NCT02286154Active, not recruiting
Therapeutic Response Evaluation and Adherence Trial (TREAT)
Therapeutic Response Evaluation and Adherence Trial (TREAT): A Prospective Study of Hydroxyurea for Children With Sickle Cell Anemia
Source: ClinicalTrials.gov · Last updated 17 Jul 2025
Brief summary (registry, in English)
The primary objectives of this prospective study of hydroxyurea for children with sickle cell anemia are 1) Develop and prospectively evaluate a population pharmacokinetic/pharmacodynamics model to predict the maximum tolerated dose (MTD); 2) Identify urine biomarkers of hydroxyurea adherence using a novel metabolomics approach; 3) Identify pharmacogenomics modifiers of hydroxyurea MTD; and 4) Longitudinal monitoring of the effect of hydroxyurea upon organ function and quality of life.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 1 Oct 2014
- Start date
- 1 Oct 2014
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Sickle cell disease
- NCT number
- NCT02286154
What you commit to
- Study type: Interventional
- Planned participants: 150
- From 1 Oct 2014 to the primary completion date, 31 Dec 2026
- 1 site 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.
Other
- 1\. Family unwillingness to sign informed consent or comply with study treatments
Who the study is looking for
- Diagnosis of sickle cell anemia (HbSS or Hbβ0-thalassemia)
- Age 6 months to 21 years at the time of enrollment
- Clinical decision by patient, family, and healthcare provider to initiate hydroxyurea therapy, including patients who are transitioning from chronic transfusions to hydroxyurea therapy
Age in the registry: 6 months to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
Related publications
- Seroprotection after measles vaccination in children with sickle cell anemia receiving hydroxyurea.Blood Adv · 2026 · PMID 42448315
This page is information, not medical advice. Discuss any trial with your doctor.