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 @ 10:06 PM
Ignite Modification Date:
2025-12-24 @ 10:06 PM
NCT ID:
NCT04171635
Eligibility Criteria:
Inclusion Criteria:
* Established diagnosis of thalassemia major
* Treatment with deferasirox formulated as Jadenu® as the sole iron chelating therapy (ICT)
* Regular transfusion with records maintained in the Cornell Thalassemia Program
* 2 years of age or older
* Females who are not pregnant
Inclusion Criteria (for healthy subjects):
* Men and women aged 21 years or older
* Able and willing to give consent
* No known hematological and liver disease
* No contraindications for MRI
Exclusion Criteria:
* A history of auditory or ocular toxicity related to ICT
* A history of poor adherence to prescribed therapy
* An inability to tolerate MRI examinations
* Treatment for mental illness
* Institutionalization or imprisonment
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT04171635
Study Brief:
Protocol Section:
NCT04171635