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 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT02208661
Eligibility Criteria:
Inclusion Criteria:
1. Documented clinical diagnosis of MPS IVA based on clinical signs and symptoms of MPS IVA and documented reduced fibroblast or leukocyte GALNS enzyme activity or genetic testing confirming diagnosis of MPS IVA.
2. Subject is at least 18 years old.
3. Subject must provide informed consent prior to study participation.
4. Subject was a participant in the MAP study (Phase I) and is now receiving (or plans to receive in the near future) enzyme replacement therapy in the EAP or commercial setting. If receiving ERT for the treatment of Morquio A syndrome, subject has been on treatment for less than 1 year.
-or-
5. Subject was not enrolled in the MAP study, but plans to start receiving ERT for Morquio A syndrome in the near future and is willing to take all baseline questionnaires which were included in MAP, prior to beginning ERT for Morquio A syndrome .
Exclusion Criteria:
* 1\. Previous treatment with ERT prior to participation in phase 1(MAP).
2\. Previous hematopoietic stem-cell transplant
3\. Patient has a clinically significant disease (with the exception of symptoms of Morquio A syndrome), including clinically significant cardiovascular, hepatic, immunologic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the investigator, would confound the effects of Morquio A syndrome upon study variables.
4\. Any condition that, in the view of the Investigator, places the patient at high risk of poor compliance or of not completing the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02208661
Study Brief:
Protocol Section:
NCT02208661