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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02824068
Eligibility Criteria:
Inclusion Criteria:
* Late-onset Pompe patients, aged over 8 years.
* The patient is willing and able to provide signed informed consent.
* The patient (and patient's legal guardian if patient is under 18 years of age) must have the ability to comply with the clinical protocol.
* Long-term Myozyme treatment beyond 36 months.
* Known GAA genotype.
* GAA activity (Dried blood spot testing, or other methods).
Exclusion Criteria:
* \- The patient is concurrently participating in another clinical study using Myozyme or other treatment.
* The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
* The patient has clinically significant organic disease (with the exception of symptoms relating to Pompe disease), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, precludes participation in the study or potentially decreases survival.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT02824068
Study Brief:
Protocol Section:
NCT02824068