1 United States site
1 Tanzania site
2 to 16 Years
– Willingness to sign informed consent
– Willingness to follow all study procedures
– Available for study visits for the duration of the study and no plans to move away
from study center.
– Confirmed diagnosis of Sickle Cell Anemia (SCA) by haemoglobin electrophoresis.
– Able to take oral medication and follow hydroxyurea treatment schedule.
There are no permanent exclusion criteria for participants to enroll in the screening TCD
portion of SPHERE. Temporary, time-limited exclusion criteria for the screening TCD portion
include the following:
– Febrile illness within the past two weeks. (Temporary Exclusion)
– Hospitalized within the past two weeks. (Temporary Exclusion)
– Transfusion within the past two weeks. (Temporary Exclusion)
Patients who enroll in the screening portion, have a conditional or abnormal TCD, and are
eligible to start hydroxyurea will be excluded from receiving study treatment if they meet
any of the following criteria:
– Abnormal pre-enrolment laboratory values (Temporary Exclusion)
– Known medical condition making participation ill-advised.
– Known allergic reactions to components of hydroxyurea.
– Previous history of stroke.
– Currently pregnant or lactating.