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Therapeutic Response Evaluation and Adherence Trial (TREAT)
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
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.
Official title: Therapeutic Response Evaluation and Adherence Trial (TREAT): A Prospective Study of Hydroxyurea for Children With Sickle Cell Anemia
Key Details
Gender
All
Age Range
6 Months - 21 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2014-10
Completion Date
2026-12
Last Updated
2025-07-17
Healthy Volunteers
No
Conditions
Interventions
Hydroxyurea
For New Cohort participants, PK/PD data will be used to predict the most effective maximum tolerated dose. Old Cohort participants will receive hydroxyurea escalated to MTD as per local clinical guidelines.
Locations (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States