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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02185651
Eligibility Criteria:
Inclusion Criteria:
Subjects will be patients between the ages of 18 years and 65 years who have been diagnosed with Pompe Disease, confirmed by mutational analysis and/or GAA enzyme activity assay.
* Receiving rhGAA ERT
* Willing to travel to the study site for study assessments
* Willingness of local medical treatment provider to continue treating study participant with addition of Zavesca® to treatment plan.
* Willingness of study participant to modify dietary intake on day of infusion \*All Subjects will continue enzyme replacement therapy as standard of care, as prescribed by local medical treatment provider during the course of the Study.
Exclusion Criteria:
* Subject is unable to meet the study requirements
* Subject's medical condition contraindicates participation or Study Investigators feel that participation is otherwise not in the Subject's best interest
* Subject does not receive ERT treatment
* Participation in other interventional studies at the time of enrollment that may interfere with this study (at the investigator's discretion)
* Unable to travel to the University of Florida for study visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02185651
Study Brief:
Protocol Section:
NCT02185651