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 @ 4:30 PM
Ignite Modification Date:
2025-12-24 @ 4:30 PM
NCT ID:
NCT04721366
Eligibility Criteria:
Inclusion Criteria:
* The participant's caregiver is able and willing to provide informed consent.
* The participant is male or female younger than or equal to 4 years of age at treatment initiation.
* The participant has received and confirmed a current diagnosis of GD type 1 or type 3 (biochemically and/or genetically).
* The participant has been receiving intravenous (IV) Velaglucerase alfa treatment for GD.
* In the opinion of the investigator, the participant's caregiver is capable of understanding and complying with protocol requirements.
* The participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion Criteria:
* The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., child, sibling) or may consent under duress.
* The participant is judged by the investigator as being ineligible for any other reason.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
5 Years
Study:
NCT04721366
Study Brief:
Protocol Section:
NCT04721366