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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT02204904
Eligibility Criteria:
Inclusion Criteria:
1. Provide informed consent from a competent custodial parent or guardian with legal capacity to execute a local Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved consent. In addition, informed assent will be sought from capable subjects, in accordance with the directive of the institution's IRB/IEC and all other local requirements.
2. Be male and ≤17 years of age at the time of treatment, for retrospective and partial prospective/retrospective subjects, or at the time of parental/guardian consent and, where appropriate, subject assent, for prospective subjects.
3. Have a confirmed diagnosis of CALD as defined by abnormal VLCFA profile and cerebral lesion on brain MRI.
4. Depending on the cohort, the subject must:
* Be scheduled for allo-HSCT evaluation at a study site (prospective cohort only),
* Have received an allo-HSC infusion and be consented in time to complete the Month 24 Visit on study (partial prospective/retrospective cohort only), or
* Have received their most recent allo-HSC infusion on or after January 1, 2013 (retrospective cohort only).
Exclusion Criteria:
1. Previous treatment with a gene therapy product.
2. Receipt of an experimental transplantation procedure.
Healthy Volunteers:
False
Sex:
MALE
Maximum Age:
17 Years
Study:
NCT02204904
Study Brief:
Protocol Section:
NCT02204904