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:
NCT00051935
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be obtained from the parent or guardian prior to performing any study related procedures;
* Patient must have a clinical diagnosis of GSD-II confirmed by endogenous GAA activity below normal in at least one tissue;
* Patient must have a sibling with a clinical diagnosis of GSD-II confirmed by an endogenous GAA activity below normal in at least one tissue, who is eligible for participation in this study;
* Patient must have a sibling with identical GAA mutations who is eligible for participation in this study;
* Patient must have a sibling with evidence of different progression of GSD-II who is eligible for participation in this study;
* The patient or his/her guardian(s) must have the ability to comply with the clinical protocol.
Exclusion Criteria:
* Patient has significant organic disease (with the exception of symptoms relating to GSD-II), including clinically significant cardiovascular, hepatic, pulmonary, neurologic, or renal disease, or other medical condition, serious intercurrent illness, or extenuating circumstance that, would preclude participation in the trial;
* Patient is participating in another investigational study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00051935
Study Brief:
Protocol Section:
NCT00051935