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 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT06184503
Eligibility Criteria:
Inclusion Criteria:
* Subjects with the provision of informed consent from their legal guardians (LAR)
* Have a confirmed diagnosis of alpha mannosidosis
* Have initiated treatment with velmanase alfa between birth to at least six weeks before turning 3 years of age
* Have information on the disease marker GlcNAc(Man)2 obtained:
before velmanase treatment initiation (ideally max 6 month before), and at least one post-treatment sample, collected following at least six weeks of treatment.
\- Participants treated with Lamzede, 1 mg/kg body weight, via weekly intravenous infusions.
Exclusion Criteria:
Participants who have undergone prior hematopoietic stem cell transplantation (HSCT) or other investigational therapies for treating alfa mannosidosis (supportive treatments acceptable).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
3 Years
Study:
NCT06184503
Study Brief:
Protocol Section:
NCT06184503