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 @ 12:59 PM
Ignite Modification Date:
2025-12-24 @ 12:59 PM
NCT ID:
NCT03399461
Eligibility Criteria:
Inclusion Criteria:
Subjects:
* Male adolescents or young adults ranging in age from 12 through 30 years old.
* Diagnosis of WAS defined by WAS genetic mutation with a clinical score \>=1 or self-reported disease severity.
* Subjects who are "conservatively managed" or have not received treatment for WAS; a maximum of 5 subjects who have received a hematopoietic stem cell transplant within the preceding two years.
* Able to read, speak, and understand English or French sufficiently to complete all assessments.
* Willing and able to participate in an audio-recorded, telephone or video conference session, including adherence to the interview instructions and completion of all questionnaires.
* Parent/guardian/patient signed informed consent.
Caregivers:
* Caregivers of children \>=2 years of age diagnosed with WAS; at least 5 caregivers of subjects under the age of 8.
* Caregivers of subjects with a diagnosis of WAS defined by WAS genetic mutation with a clinical score \>=1 or self-reported disease severity.
* Caregivers of subjects who are "conservatively managed" or have not received treatment for WAS; At least 2 caregivers of subjects who have received a hematopoietic stem cell transplant within the preceding two years.
* Caregivers are defined as primary caregiver.
* Able to read, speak, and understand English or French sufficiently to complete all assessments.
* Willing and able to participate in an audio-recorded, telephone or video conferencing interview session, including adherence to the interview instructions and completion of all questionnaires.
* Caregivers of Wiskott-Aldrich patients can be of any age or gender and do not have to follow the patient inclusion criteria, as long as their child/patient meets the inclusion criteria, as outlined.
Exclusion Criteria:
Subjects
* Subjects who have previously received gene therapy treatment Caregivers
* Caregivers of subjects who have previously received gene therapy treatment
* Professional caregivers (that is, at home nurse or equivalent).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
30 Years
Study:
NCT03399461
Study Brief:
Protocol Section:
NCT03399461