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 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 12:11 AM
NCT ID:
NCT00074958
Eligibility Criteria:
Inclusion criteria:
* Patient or legal guardian must provide written informed consent
* Patients must have a clinical diagnosis of Fabry disease and active Fabry disease (clinical signs and symptoms)
* Patients must be at least 7 years of age but no older than 15 years of age at time of enrollment
* Patients must be Tanner Stage ≤ III
* Female patients must have a negative pregnancy test prior to each infusion and use a medically accepted form of contraception throughout the study
Exclusion Criteria:
* Patient has a clinically significant organic disease (with the exception of symptoms relating to Fabry disease) that in the opinion of the investigator would preclude participation in the trial
* Patient has participated in a study employing investigational drug within 30 days of the start of this study
* Patient has received prior treatment with enzyme replacement therapy
* Patient is unable to comply with the clinical protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
15 Years
Study:
NCT00074958
Study Brief:
Protocol Section:
NCT00074958