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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT05725902
Eligibility Criteria:
Inclusion Criteria:
* Homozygous hemoglobin SS (HbSS) or hemoglobin S/beta0 thalassemia (HbS/β0 thal)
* Hemoglobin (Hb): Hb ≤ 9.0 g/dL at baseline
* Concomitant hydroxyurea (HU) therapy is allowed if the dose has been stable for at least 3 months with no anticipated need for dose adjustments during the study and no sign of hematological toxicity
Exclusion Criteria:
* Any one of the following requiring a medical facility visit within 14 days prior to signing the informed consent form:
* Vaso-occlusive crisis (VOC)
* Acute chest syndrome (ACS)
* Splenic sequestration
* Dactylitis
* Requires chronic transfusion therapy
* Abnormal TCD in the last 12 months
* RBC transfusion within 60 days of screening
* Severe renal dysfunction at the Screening Visit or on chronic dialysis
* Hepatic dysfunction
* Clinically relevant cardiac or pulmonary disease- e.g., congenital heart defect, uncompensated heart failure, or any unstable cardiac condition, arrhythmic heart condition, pulmonary fibrosis, pulmonary hypertension
* Major surgery involving the stomach or small intestine
* Chemotherapy or radiation within the past 2 years
* History of overt clinical stroke within previous 2 years or any history of an intracranial hemorrhage
* Clinically significant bacterial, fungal, parasitic, or viral infection currently receiving or that will require therapy
* Female who is breast feeding or pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
21 Years
Study:
NCT05725902
Study Brief:
Protocol Section:
NCT05725902