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 @ 12:17 PM
Ignite Modification Date:
2025-12-24 @ 12:17 PM
NCT ID:
NCT03702361
Eligibility Criteria:
Inclusion Criteria:
* Males and females, 18 years or older for the first ten adult patients; 6 years or older for the last five patients.
* Confirmed enzymatic diagnosis of Gaucher disease with a defined genotype and elevated biomarker LysoGb1, performed at CentoGene using DBS methodology.
* Indications for ERT will be guided by fulfilling the MOH criteria.
* Female patients of child-bearing potential who agree to use a medically acceptable method of contraception.
* Patients who have not received ERT or SRT in the past or Patients who have not received ERT or SRT in the past 12 months and have a negative anti-glucocerebrosidase antibody
Exclusion Criteria:
* Currently taking another experimental drug for any condition
* Presence of neurologic signs and symptoms characteristic of Type 2 or Type 3 Gaucher disease
* Pregnant or nursing
* Presence of any medical, emotional, behavioral or psychological condition that in the judgment of the Investigator would interfere with the patient's compliance with the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
75 Years
Study:
NCT03702361
Study Brief:
Protocol Section:
NCT03702361