Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 12:43 AM
NCT ID:
NCT03948867
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
16 Years
Study:
NCT03948867
Study Brief:
Protocol Section:
NCT03948867