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 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT00312767
Eligibility Criteria:
Inclusion Criteria:
* Patient must provide signed, written informed consent prior to any study-related procedures being performed.
* Patient is between 18 and 65 years of age, inclusive.
* Patient has documented Fabry disease.
* Patient has received bi-weekly 1 mg/kg infusions of Fabrazyme for at least 6 months prior to enrollment into the study.
* Patient has not experienced moderate or severe infusion-associated reactions (IARs) from Fabrazyme infusions, which were also associated with a rate reduction, within 3 months prior to enrollment into the study.
* Patient has been receiving chronic hemodialysis for treatment of end-stage renal insufficiency for at least 3 months prior to enrollment into the study.
* Patient has good vascular access for hemodialysis.
* Patient has not and will not have any other (investigational) drug(s) infused during their hemodialysis, and is expected to have a stable concomitant medication regimen at all PK assessments.
Exclusion Criteria:
* Patient's hemoglobin is \< 9 g/100 mL at Screening/Baseline.
* Patient has a clinically significant organic disease or an unstable condition that, in the opinion of the Investigator, would preclude participation in the study.
* Patient has a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance.
* Patient has participated in a study employing an investigational drug within 30 days prior to the start of their participation in this study.
* Patient is unwilling to comply with the requirements of the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00312767
Study Brief:
Protocol Section:
NCT00312767