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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT04591834
Eligibility Criteria:
Inclusion Criteria:
1. Meets any of the following criteria:
1. Has a clinical diagnosis of severe MPS II and has a documented mutation in IDS, OR
2. Has a relative clinically diagnosed with severe MPS II who has the same IDS mutation as the subject, OR
3. Has documented mutation(s) in IDS that in the opinion of the investigator is known to result in a neuronopathic phenotype
2. Has sufficient communication capacity to complete the required protocol testing
Patient's legal guardian must be willing and able to provide written, signed informed consent.
Exclusion Criteria:
1. Has had prior treatment with an AAV-based gene therapy product
2. Is currently participating in a clinical trial of an investigational product for the treatment of MPS II with the exception of IT ELAPRASE trials; no investigational product may be taken starting 30 days or 5 half-lives of the investigational product prior to signing the ICF, whichever is longer
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
1 Month
Maximum Age:
8 Years
Study:
NCT04591834
Study Brief:
Protocol Section:
NCT04591834