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:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
NCT ID:
NCT00299000
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent by a parent or legal guardian
* Parent or legal guardian willing and able to comply with all study procedures
* Equal to or greater than 36 weeks estimated gestational age by physical exam at birth
* Has a diagnosis of MPS VI based on a documented prenatal diagnosis or fibroblast or leukocyte N-acetylgalactosamine 4-sulfatase (ASB) enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory
* Is less than one year of age
* Has no evidence of skeletal dysplasia based on physical exam
Exclusion Criteria:
* Parent of legal guardian perceived to be unreliable or unavailable for study participation
* Use of any investigational drug within 30 days prior to screening, or requirement for any investigational agent prior to completion of all scheduled study assessments
* Has concurrent disease or condition that would interfere with study participation or safety (i.e., has previously undergone hematopoietic stem cell transplantation such as bone marrow or cord blood transplantation, or major organ transplantation)
* Any condition that, in the view of the principle investigator, renders the subject at high risk from treatment compliance and/or completing the study
* Has known hypersensitivity to Naglazyme
* Has previously received Naglazyme
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Year
Study:
NCT00299000
Study Brief:
Protocol Section:
NCT00299000