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 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT00030134
Eligibility Criteria:
The patient must provide written informed consent prior to any study-related procedures being performed.
Patients must be 18 years of age or older.
Patients must have signs of symptoms consistent with Fabry disease with no prior treatment with any enzyme replacement therapy for Fabry Disease.
Patients of childbearing potential must have a negative pregnancy test (urine beta-hCG) in order to complete all study tests.
If a patient is pregnant, they may still enter the trial but may not participate in MRI or MRA procedures.
Patients who have received an investigational drug within 30 days prior to study enrollment or received prior treatment with any enzyme replacement therapy for Fabry disease will be excluded.
Patients who have diabetic nephropathy or other confounding renal disorder will be excluded.
Patients who have a clinically significant organic disease or an unstable condition that, in the opinion of the Investigator, would preclude participation in this protocol will be excluded.
Healthy Volunteers:
False
Sex:
FEMALE
Study:
NCT00030134
Study Brief:
Protocol Section:
NCT00030134