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:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00885833
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Wiskott-Aldrich syndrome with gene analysis.
2. Indicated for hematopoietic stem cell transplantation.
3. Age: no limitation.
4. Performance status: ECOG 0-2.
5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases:
* Heart: a shortening fraction \> 30%, ejection fraction \> 45%.
* Liver: total bilirubin \< 2 × upper limit of normal; ALT \< 3 × upper limit of normal.
* Kidney: creatinine \<2 × normal or a creatinine clearance (GFR) \> 60 ml/min/1.73m2.
6. Patients must lack any active viral infections or active fungal infection.
7. Appropriate hematopoietic stem cell donor is available.
8. Patients (or one of parents if patients age \< 19) should sign informed consent.
Exclusion Criteria:
1. Pregnant or nursing women.
2. Malignant (except acute myeloid leukemia) or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy.
3. Psychiatric disorder that would preclude compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
25 Years
Study:
NCT00885833
Study Brief:
Protocol Section:
NCT00885833