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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT05447494
Eligibility Criteria:
Inclusion Criteria:
* Subjects have a confirmed clinical, enzymatic, and genetic diagnosis of Gaucher disease (Type 1 or Type 3);
* Phase 1: Subjects with GD1 aged ≥18 years; Phase 2: Subjects with GD1 or GD3 aged ≥12 years;
* Subjects have not received enzyme replacement therapy (ERT) or substrate replacement therapy (SRT) within 3 months before screening;
* Subjects have GD-related anemia and one or more of the following disease manifestations:
1. Spleen volume ≥2 MN as measured by MRI, or
2. Liver volume ≥1.5 MN as measured by MRI, or
3. Platelet count ≥20 × 10\^9/L and \<100×10\^9/L.
Exclusion Criteria:
* Subjects have received or stopped treatment with other investigational drugs or devices within 30 days before screening or less than 5 half-lives, whichever is longer (drugs only);
* Subjects have anemia due to other causes during screening, including nutritional anemia. Subjects whose nutritional anemia recovers with the treatment of iron, folic acid, or Vitamin B12 may be rescreened;
* Subjects have received hepatectomy or splenectomy;
* Subjects have had an allergic reaction to imiglucerase or other ERTs and their components;
* Subjects have received treatment with erythropoietin, whole blood or packed red blood cell transfusions, or chronic systemic corticosteroids within 3 months before screening, or have received a platelet transfusion within 1 month before screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT05447494
Study Brief:
Protocol Section:
NCT05447494