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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT00113035
Eligibility Criteria:
Inclusion Criteria:
* Must provide written informed consent prior to any study-related procedures being performed
* Clinical presentation consistent with late-onset Pompe disease, or a current clinical diagnosis of late-onset Pompe disease
* Must be greater than or equal to 8 years of age
* Must be able to ambulate (use of assistive devices, such as a walker, cane or crutches, is permitted)
Exclusion Criteria:
* Requires the use of invasive ventilatory support
* Requires the use of noninvasive ventilatory support while awake and in an upright position
* Use of any investigational product within 30 days prior to study enrollment
* Unwillingness to comply with protocol requirements
* Has clinically significant organic disease, unstable medical condition, serious or intercurrent illness
* Is pregnant or lactating
* Has participated in the Prospective Observational Study in Patients with Late-Onset Pompe Disease (AGLU02303, "LOPOS")
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT00113035
Study Brief:
Protocol Section:
NCT00113035