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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00864851
Eligibility Criteria:
Inclusion Criteria:
* \>18 years-old;
* Male:Fabry disease confirmed by deficiency of alfa galactosidase A activity OR Female:Fabry disease confirmed by a mutation of the alfa galactosidase A gene;
* ERT-naïve;
* LVM/h \> 50g/m2.7 for males and \>47 g/m2.7 for females;
* Negative pregnancy test at enrollment and contraception use required throughout study for female patients;
* Signed informed consent;
Exclusion Criteria:
* Class IV heart failure;
* Clinically significant hypertension;
* Hemodynamically significant valvular stenosis or regurgitation;
* Morbid obesity;
* Known autosomal dominant sarcoplasmic contractile protein gene mutation;
* Treatment with any investigational drug or device within the 30 days;
* Unable to comply with the protocol as determined by the Investigator;
* Positive for hepatitis B, hepatitis C or HIV
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00864851
Study Brief:
Protocol Section:
NCT00864851