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:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
NCT ID:
NCT06561061
Eligibility Criteria:
Inclusion Criteria:
* Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
* Age range of 1.00-4.99 years, inclusive, at the time of enrollment
* Weight at least 5.0 kg at the time of enrollment
* Willingness to comply with all study-related treatments, evaluations, and follow-up
* Children whose parents or guardians give full written informed consent
Exclusion Criteria:
* Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
* Severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age z-score \<-3, using WHO growth standards)
* Absolute neutropenia (absolute neutrophil count \<500)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
59 Months
Study:
NCT06561061
Study Brief:
Protocol Section:
NCT06561061