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 @ 3:14 PM
Ignite Modification Date:
2025-12-24 @ 3:14 PM
NCT ID:
NCT04462692
Eligibility Criteria:
Inclusion Criteria:
A participant is eligible to be included in the study only if all of the following criteria apply:
1. His or her legal guardian(s) is(are) willing and able to provide them written, signed informed consent.
2. Has documented diagnosis of CLN2 disease due to TPP1 deficiency, or has a relative clinically diagnosed with CLN2 with the same mutation as the participant
3. Is currently receiving biweekly ERT treatment with cerliponase alfa
Exclusion Criteria:
A participant is excluded from the study if any of the following criteria apply:
1. Has had prior treatment with an adeno-associated virus-based AAV gene therapy
2. Is currently participating in a clinical trial of investigational product for the treatment of CLN2 disease
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04462692
Study Brief:
Protocol Section:
NCT04462692