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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT07003269
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with severe thalassemia via thalassemia gene testing, transfusion history, and complete blood count (CBC).
* Pediatric patients aged 2-17 years.
* Consented to haploidentical transplantation and evaluated by the transplant team as having no transplant contraindications.
Exclusion Criteria:
* Presence of a fully matched donor with refusal of haploidentical transplantation.
* Donor or recipient with transaminase levels \>2× the upper limit of normal (ULN).
* Positive hepatitis B DNA test result.
* Active infection at the time of enrollment.
* Donor-specific antibodies (DSA) \>5,000 and unable to decrease below 3,000 after antibody therapy.
* Presence of transplant contraindications as assessed by the transplant team.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT07003269
Study Brief:
Protocol Section:
NCT07003269