NCT04750707View on ClinicalTrials.gov

Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II )

PHASE3CompletedINTERVENTIONAL
Enrollment

270

Participants

Timeline

Start Date

March 9, 2021

Primary Completion Date

March 10, 2025

Study Completion Date

March 10, 2025

Conditions
Sickle Cell Anemia in Children
Interventions
DRUG

Hydroxyurea

The study intervention will be daily oral Hydroxyurea given in single doses starting at approximately 20mg/kg/day and escalated to a maximum 30mg/kg/day depending on clinical need and according to standard guidelines.

Trial Locations (1)

+256

Global Health Uganda, Kampala

All Listed Sponsors
collaborator

Columbia University

OTHER

collaborator

University of Pittsburgh

OTHER

collaborator

Emory University

OTHER

collaborator

Mulago Hospital, Uganda

OTHER

collaborator

Makerere University

OTHER

collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Global Health Uganda LTD

OTHER

NCT04750707 - Hydroxyurea Therapy for Neurological and Cognitive Protection in Pediatric Sickle Cell Anemia in Uganda ( BRAINSAFE-II ) | Biotech Hunter | Biotech Hunter