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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00661804
Eligibility Criteria:
Inclusion Criteria for People with Thalassemia:
* Thalassemia, as documented by clinical diagnosis, including the following types:
1. Beta-thalassemia (intermedia or major)
2. Hemoglobin H (HbH) disease
3. HbH with non-deletional mutations (e.g., HbH Constant Spring)
4. E-beta-thalassemia
5. Homozygous alpha-thalassemia (i.e., 4-gene alpha deletion or equivalent null alpha mutation)
6. Other thalassemic conditions not explicitly excluded
7. Thalassemia intermedia due to heterozygous beta mutation with alpha-gene excess
* Requires at least annual monitoring for end-organ injury related to thalassemia, including all clinical measures specified in this study
Inclusion Criteria for People who Have Received a Successful Stem Cell Transplant:
* Received a successful hematopoietic stem cell transplant, defined as engraftment of all three cell lines and transfusion independence by 100 days post-transplant, for any of the thalassemia disorders listed above
* Monitored for end-organ injury related to thalassemia before their successful stem cell transplant, including all clinical measures specified in this study
Exclusion Criteria for People with Thalassemia:
* Has any of the following mild or mixed diagnoses:
1. Thalassemia trait (i.e., single recessive beta-gene mutation, two-gene alpha-gene mutation)
2. Thalassemia/Hb S, C, or D compound heterozygotes
3. HbH with steady state hemoglobin above 9.0 g/dL and no history of significant thalassemia complications (e.g., endocrinopathies, cardiac dysfunction, growth impairment, pulmonary hypertension)
* Unable or unwilling to be followed annually
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT00661804
Study Brief:
Protocol Section:
NCT00661804