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:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-26 @ 11:12 AM
NCT ID:
NCT05469828
Eligibility Criteria:
Inclusion Criteria (Both Patient Groups - 1. SCD on SEG101 and 2. SCD not receiving SEG101)
* We will enroll only SS and Sß0 sickle cell disease patients
* Both male and female will be included.
* Our population of sickle cell disease is 90% African American and 10% Hispanic, therefore, our study population will reflect that distribution of ethnicity.
* Informed consent from legal guardian and/or patient
* Able to participate without needing sedation for MRI scan
* Age at least 16 years
Exclusion Criteria (Both Patient Groups - 1. SCD on SEG101 and 2. SCD not receiving SEG101)
* Any pain crisis requiring an ER visit and/or admission to the hospital and/or required parenteral pain medication in the previous 4 weeks.
* Any acute transfusion in the previous 4 weeks
* Need for chronic transfusion therapy
* Any known chronic illness that in the judgment of the investigator may compromise subject safety or data integrity. These include but are not limited to rheumatologic disorders, malignancy, severe asthma, chronic hepatic or renal insufficiency.
* Known pregnancy
* Seizure disorder
* Inability to cooperate with MRI examinations
* Contraindication to Crizanlizumab
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05469828
Study Brief:
Protocol Section:
NCT05469828