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 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT00787995
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written, signed informed consent, or in the case of subjects age \< 18 years, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Documented history of reduced GALNS activity relative to the normal range of the laboratory performing the assay, or documented result of molecular genetic testing confirming diagnosis of MPS IVA.
* Willing and able to comply with all study procedures.
Exclusion Criteria:
* Use of any investigational product or investigational medical device within 30 days prior to screening.
* Previous hematopoietic stem cell transplant (HSCT).
* Concurrent disease or condition that would interfere with study participation or pose a safety concern.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00787995
Study Brief:
Protocol Section:
NCT00787995