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 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT04925206
Eligibility Criteria:
Key Inclusion Criteria:
* Subjects and/or legal representative fully understand and voluntarily sign informed consent forms.
* Diagnosis of transfusion dependent β-thalassemia (β-TDT) as defined by protocol.
* Be not appropriate to receive conventional allogeneic hematopoietic stem cell transplantation.
* Lansky/Karnofsky score ≥ 70%.
* Eligible for hematopoietic stem cell transplantation and conditioning with busulfan as per investigator's judgement.
Other protocol defined inclusion criteria may apply.
Key Exclusion Criteria:
* Subjects with associated α-thalassemia.
* Subjects with any clinically significant acute or uncontrolled infections.
* History of uncontrolled epilepsy or other mental disorders.
* Previous treatment with allogeneic bone marrow transplantation or gene therapy.
Other protocol defined exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
35 Years
Study:
NCT04925206
Study Brief:
Protocol Section:
NCT04925206