Alternative Dosing And Prevention of Transfusions (ADAPT)

EARLY_PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 16, 2022

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Sickle Cell Disease
Interventions
DRUG

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.

Trial Locations (1)

Unknown

Jinja Regional Referral Hospital (JRRH), Department of Paediatrics, Sickle Cell Clinic, Jinja

All Listed Sponsors
collaborator

Jinja Regional Referral Hospital (JRRH), Sickle Cell Clinic, Jinja, Uganda

UNKNOWN

lead

Children's Hospital Medical Center, Cincinnati

OTHER