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:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT03128593
Eligibility Criteria:
Inclusion Criteria:
* Patients aged 6 years or older at the time of informed consent.
* Patients diagnosed with MPS II.
* Patients who have received idursulfase (0.5 mg/kg/week) continuously for at least 12 weeks until the initial dose of JR-141.
Exclusion Criteria:
* Patients with a history of hematopoietic stem cell transplantation, excluding those who need enzyme replacement therapy even after hematopoietic stem cell transplantation.
* Patients in whom lumbar puncture cannot be performed.
* Patients who have developed serious drug allergy or hypersensitivity that is inappropriate for participation in the study.
* Patients who have received other investigational products within 4 months before enrollment in the study.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
6 Years
Study:
NCT03128593
Study Brief:
Protocol Section:
NCT03128593