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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT00578292
Eligibility Criteria:
Inclusion Criteria:
Patients with documented diagnosis of severe (transfusion-dependent) homozygous b0/+-thalassemia or severe variants of b0/+-thalassemia requiring chronic transfusion therapy and iron chelating agents, who fulfill the following conditions:
1. Patient does not have an HLA genotype-identical donor available and has a 5/6 or 6/6 matched unrelated donor, or a 5/6 matched related donor available.
2. Must be between 1 and 16 yrs of age (all Pesaro risk groups).
3. Patients older than 17 yrs of age must be in Pesaro Risk Class 2 or lower (see Appendix B).
4. Women of childbearing potential must have a negative pregnancy test.
5. Documentation of compliance with iron chelation, absence or presence of hepatomegaly, and presence or absence of hepatic fibrosis prior to transplant (criteria for the Pesaro Risk Classification). This information will be obtained by history, physical exam and interpretation of liver biopsy results.
6. Documentation of awareness of alternative treatment options.
Exclusion Criteria:
1. Biopsy-proven chronic active hepatitis or fibrosis with portal bridging.
2. Has previous history of malignancies.
3. Creatinine clearance \< 35 mL/min/1.73 M2.
4. Severe cardiac dysfunction defined as shortening fraction \< 25%.
5. HIV infection.
6. Inadequate intellectual capacity to give informed consent (in the case of minors, this criteria must be fulfilled by the legal guardian).
7. Be pregnant, lactating or unwilling to use appropriate birth control.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
64 Years
Study:
NCT00578292
Study Brief:
Protocol Section:
NCT00578292