Stroke Prevention With Hydroxyurea Enabled Through Research and Education (SPHERE)

Phase 2 Enrolling by invitation 202 enrolled Children's Hospital Medical Center, Cincinnati Bugando Medical Centre · collab The American Society of Hematology · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will 1) Evaluate the prevalence of elevated (conditional or abnormal) transcranial Doppler (TCD) velocities in a cross-sectional analysis of children with Sickle Cell Anemia (SCA) living in Tanzania; 2) Obtain longitudinal data on TCD velocities in this population; and 3) Measure the effects of hydroxyurea therapy on TCD velocities and associated primary stroke risk.

Timeline

Start: 2019-04-24
Primary completion: 2026-12-31
Completion: 2026-12-31

Outcome

Met primary endpoint

paper which was significantly lower than baseline (p<0·0001) PMID 36870358 ↗

Publications

Ambrose EE, Latham TS, Songoro P, Charles M, Lane AC, Stuber SE, Makubi AN, Ware RE, Smart LR. Hydroxyurea with dose escalation for primary stroke risk reduction in children with sickle cell anaemia in Tanzania (SPHERE): an open-label, phase 2 trial. Lancet Haematol. 2023 Apr;10(4):e261-e271. doi: 10.1016/S2352-3026(22)00405-7. Epub 2023 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hydroxyurea	Other / unclassified	—	Oral