100
Participants
Start Date
June 16, 2022
Primary Completion Date
December 31, 2026
Study Completion Date
December 31, 2027
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.
Jinja Regional Referral Hospital (JRRH), Department of Paediatrics, Sickle Cell Clinic, Jinja
Jinja Regional Referral Hospital (JRRH), Sickle Cell Clinic, Jinja, Uganda
UNKNOWN
Children's Hospital Medical Center, Cincinnati
OTHER