NotablePrimary and study completion dates: Jul 30, 2021 to Jan 31, 2034v35
Study Status, Referencesv34
MinorPrimary and study completion dates: Dec 31, 2021 to Jul 30, 2021v33
MinorPrimary and study completion dates: Jul 30, 2021 to Dec 31, 2021v32
MinorStudy sites: 64 to 203v31
NotablePrimary and study completion dates: Sep 2022 to Jul 30, 2021v30
NotablePrimary and study completion dates: Jul 30, 2021 to Sep 2022v29
NotablePrimary and study completion dates: Jan 30, 2030 to Jul 30, 2021v28
NotablePrimary and study completion dates: Jul 2021 to Jan 30, 2030
Start date: Jul 2001 to Jul 31, 2001
v27
NotablePrimary and study completion dates: Jul 2030 to Jul 2021v26
NotablePrimary and study completion dates: Jul 2021 to Jul 2030v25
NotablePrimary and study completion dates: Jul 2030 to Jul 2021v24
MinorStudy sites: 1 to 64v23
MinorPrimary and study completion dates: Jan 2030 to Jul 2030v22
NotablePrimary and study completion dates: Jul 2020 to Jan 2030
Start date: Apr 2001 to Jul 2001
v21
Re-verified, no change to tracked fieldsv20
MinorEligibility criteria expanded, about 1 wordv19
Re-verified, no change to tracked fieldsv18
MinorEnrollment target: 9000
Primary and study completion dates: Jul 2020
v17
Study Status, Study Descriptionv16
2 versionsRe-verified since Dec 8, 2011, no change to tracked fieldsv14-v15
Study Status, Arms and Interventionsv13
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The Fabry Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Fabry disease, irrespective of treatment status. No experimental intervention is involved; patients in the Registry undergo clinical assessments and receive care as determined by the patient's treating physician.
The primary objectives of the Registry are:
* To enhance the understanding of the variability, progression, and natural history of Fabry disease, including heterozygous females with the disease;
* To assist the Fabry medical community with the development of recommendations for monitoring patients and reports on patient outcomes to help optimize patient care;
* To characterize and describe the Fabry population as a whole;
* To evaluate the long-term safety and effectiveness of Fabrazyme®
Fabry Pregnancy Sub-registry: This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Fabry Registry, regardless of whether she is receiving disease-specific therapy (such as enzyme replacement therapy with agalsidase beta) and irrespective of the commercial product with which she may be treated. Data from the Sub-registry are also used to fulfill various global regulatory requirements, to support product development/reimbursement, and for other research and non-research-related purposes. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. If a patient consents to this Sub-registry, information about the patient's medical and obstetric history, pregnancy, and birth will be collected, and, if a patient consents to data collection for her infant, data on infant growth through month 36 postpartum will be collected.