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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT02721420
Eligibility Criteria:
Inclusion Criteria:
1. Haemoglobin \<5.0g/dl or PCV \<15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital
2. Age between 4 months (inclusive) and 59 months (inclusive)
3. Body weight \>5kgs
Screening (in-hospital):
1. Fulfilled the pre-study screening eligibility criteria
2. Clinically stable, able to switch to oral medication
3. Subject completed blood transfusion(s) in accordance with routine hospital practice
4. Able to feed (for breastfed children) or eat (for older children)
5. Absence of known cardiac problems
6. Provision of informed consent by parent or guardian
Randomization (at discharge):
1. Fulfilled screening eligibility criteria
2. Still clinically stable, able to take oral medication, able to feed (for breastfed children) or eat (for older children) and able to sit unaided (for older children who were able to do so prior to hospitalization
Exclusion Criteria:
1. Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)
2. Known sickle cell
3. Child will reside for more than 25% of the 3.5months study period (i.e. 3 weeks or more) outside of catchment area Enrolment in the study (t=0) at discharge
4. Previous enrolment in the present study
5. Known hypersensitivity to study drug
6. Sickle cell disease
7. Known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.
8. On-going or planned participation into another clinical trial involving on-going or scheduled treatment with medicinal products during the course of the study (3.5 months from enrolment)
9. Known need, or scheduled surgery during the course of the study (3.5 months)
10. Suspected non-compliance with the follow-up schedule
11. Known heart conditions, or family history of congenital prolongation of the QTc interval
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Months
Maximum Age:
59 Months
Study:
NCT02721420
Study Brief:
Protocol Section:
NCT02721420