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Alternative Dosing And Prevention of Transfusions (ADAPT)
Sponsor: Children's Hospital Medical Center, Cincinnati
Summary
ADAPT is a prospective cohort study at Jinja Regional Referral Hospital (JRRH) primarily to assess the effect of hydroxyurea on blood transfusion utilization and secondarily to determine the feasibility of PK-guided hydroxyurea dosing.
Official title: Alternative Dosing And Prevention of Transfusions (ADAPT): A Prospective Study to Reduce Transfusion Requirements for Children With Sickle Cell Anemia Using Pharmacokinetics-based Hydroxyurea Dosing
Key Details
Gender
All
Age Range
12 Months - 10 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-06-16
Completion Date
2027-12-31
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
Hydroxyurea
All participants will receive an individualized PK hydroxyurea assessment. Participants for whom the PK-process successfully generates a dose in the predicted treatment range of 15-35 mg/kg/day, will start on that personalized dose. Participants for whom the process does not generate a starting hydroxyurea dose in the predicted treatment range, due to potential pitfalls in lab draws, serum storage, sample processing, or hydroxyurea analysis, will start at a default dose of 20.0 ± 2.5 mg/kg/day. For all participants, the hydroxyurea dose will be adjusted as needed based on blood counts to establish the optimal dose. Where necessary, a weekly dosing average will be determined, so that treatment can occur solely with locally available and affordable 500mg hydroxyurea capsules.
Locations (1)
Jinja Regional Referral Hospital (JRRH), Department of Paediatrics, Sickle Cell Clinic
Jinja, Uganda