Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II

PHASE3CompletedINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

July 19, 2016

Primary Completion Date

March 3, 2020

Study Completion Date

March 3, 2020

Conditions
Sickle Cell DiseaseStroke
Interventions
DRUG

Hydroxyurea (Moderate Dose)

The study intervention will include moderate dose hydroxyurea therapy at 20 mg/kg/day (range 17.5 - 26 mg/kg/day) for 36 months.

DRUG

Hydroxyurea (Low Dose)

The study intervention will include random allocation to low dose hydroxyurea therapy at 10 mg/kg/day (range 7 - 15 mg/kg/day) for 36 months.

Trial Locations (3)

Unknown

Barau Dikko Teaching Hospital/Kaduna State University, Kaduna

Aminu Kano Teaching Hospital, Kano

Murtala Muhammad Specialist Hospital, Kano

All Listed Sponsors
collaborator

Aminu Kano Teaching Hospital

OTHER

collaborator

Murtala Muhammed Specialist Hospital

OTHER

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

collaborator

Barau Dikko Teaching Hospital/Kaduna State University

UNKNOWN

lead

Vanderbilt University Medical Center

OTHER

NCT02560935 - Primary Prevention of Stroke in Children With SCD in Sub-Saharan Africa II | Biotech Hunter | Biotech Hunter