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 @ 5:20 PM
Ignite Modification Date:
2025-12-24 @ 5:20 PM
NCT ID:
NCT03950050
Eligibility Criteria:
Inclusion Criteria:
\*Adult patients ≥ 18 years with type 1 GD and suboptimal response to ERT defined as one or more than one of the following: platelet count \< 100 x 103/mm3 bone mineral density \< -2 T score Lyso-GB1 \> 200 ng/ml.
\*No change in dose or preparation of ERT in the last 12 months (Except for Naive patients)
Exclusion Criteria:
* Patients with comorbidity that may impact on the primary and/or secondary endpoint.
* Pregnant women will be excluded from the study.
* Inability to cooperate with the study procedure
* Hypersensitivity or any other contraindication listed in the local labeling of ambroxol
* Refusal of patients to participate in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03950050
Study Brief:
Protocol Section:
NCT03950050