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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT04031066
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of alpha-mannosidosis based on alpha mannosidase activity \<10% of normal in leukocytes or fibroblasts or through genetic testing;
* Capability to comply with the protocol;
* Evidence of informed consent provided by subject or legally authorized guardian(s) prior to performance of any trial-related activities.
Exclusion Criteria:
* Previous hematopoietic stem cells transplantation (HSCT) with positive outcome;
* Major surgery planned within 3 months prior to study entry or planned during the study that, in the opinion of the Investigator, would preclude participation in the trial;
* Known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition that would preclude participation in the study in the Investigator's judgment;
* Pregnant (as evident by a positive urine hCG or serum-hCG test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential \[WOCBP\]) UNLESS they are willing to use highly effective birth control methods;
* Participation in other interventional trials testing investigational medicinal products (IMPs) within the last 6 months;
* Total IgE \>800 IU/ml;
* Any hypersensitivity to velmanase alfa or its excipients that, in the judgment of the Investigator, places the subject at an increased risk for adverse reactions
* Clinically active infection and recent vaccinations (within the last month before screening).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04031066
Study Brief:
Protocol Section:
NCT04031066