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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT02520934
Eligibility Criteria:
Case\_Miglustat
Inclusion Criteria:
1. Confirmed diagnosis of Gaucher Disease: blood test shown lack of beta- glucocerebrosidase, and found L444P homozygous on GBA gene.
2. Aged 6 years old or above.
3. Already have regular ERT (30-120 IU/kg/ every 2 weeks) at least a year; dosage and frequency of ERT had not been changed in recent 3 months.
Exclusion Criteria:
1. History of tremor and abnormal extremities perception ( pain, numbness, tingle etc.)
2. Abnormal kidney function.
3. Pregnant or plan to have a baby ( potentially pregnant patient need to be transferred to gynecologist for the test and promise to have proper contraception measures).
4. Allergic to Miglustat.
Control\_normal Inclusion Criteria
1. Age 6-18 years
2. No significant physical, mental, or psychiatric problems
Exclusion criteria
1\. Children with eye disease (not include myopia, hyperopia, Astigmatism)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT02520934
Study Brief:
Protocol Section:
NCT02520934