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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT06761560
Eligibility Criteria:
Inclusion Criteria (Group A and B) :
* Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis.
* Be patients with SS, SBThal0.
* Agree to take hydroxyurea for a period of 12 months
* Be between age of 6months old and 18 years old.
* Have consented for participation in the study.
Inclusion Criteria (Group C) :
* Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis.
* Be patients with SS, SBThal0.
* Have taken hydroxyurea for a period of at least 12 months, and have received HU at a stable dose and at MTD for at least 6 months.
* Be between age of 6months old and 18 years old.
* Have consented for participation in the study.
Exclusion Criteria:
* Patients with sickle cell genotype other than SS or SBThal0 (SC, SBThal+, SE or SD)
* Patients on chronic transfusion program
* Patients have received a blood transfusion in the last 4 weeks of study enrollment.
* Have received a hematopoietic stem-cell transplantation
* Creatinine \>2x normal for age
* ALT\>2x normal for age
* Sexually active females unwilling to comply with reliable method of birth control
* Pregnancy
* Conditions which in the opinion of the investigator, would compromise participation in the study will be excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
18 Years
Study:
NCT06761560
Study Brief:
Protocol Section:
NCT06761560