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 @ 11:03 PM
Ignite Modification Date:
2025-12-24 @ 11:03 PM
NCT ID:
NCT07285369
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients aged 3 to 18 years
* Genetically confirmed Type III Gaucher Disease (GD3)
* Treatment naïve or receiving enzyme replacement therapy (ERT)
* SARA score ≥ 8
* Sexually active females must agree to use contraception
* All participants must not be pregnant or breastfeeding
Exclusion Criteria:
* Life-threatening visceral disease (related or unrelated to Gaucher Disease)
* Blood transfusion dependency
* Clinically significant cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, or psychiatric conditions
* Serious swallowing difficulties
* Renal insufficiency (eGFR \< 30 mL/min/1.73 m²)
* Recent chaperone therapy or investigational treatment within the last 6 months
* Pregnancy or lactation
* History of cancer, drug or alcohol abuse, major organ transplant, or inability to adhere to study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT07285369
Study Brief:
Protocol Section:
NCT07285369