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Fabry Disease Registry & Pregnancy Sub-registry
NCT00196742 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (20)
California
- University of California at Irvine- Site Number : 840036 — Irvine
- Southern California Permanente Medical Group- Site Number : 840108 — Los Angeles
- USC Health Sciences Center Dept of Genetics- Site Number : 840082 — Los Angeles
- UCLA School Of Medicine- Site Number : 840088 — Los Angeles
- UCSF Benioff Children's Hospital - Oakland- Site Number : 840029 — Oakland
- Children's Hospital of Orange County- Site Number : 840074 — Orange
- Stanford Unviersity MC Dept of Genetics- Site Number : 840022 — Palo Alto
- UC Davis MIND Institute- Site Number : 840010 — Sacramento
- Kaiser Permanente Sacramento Medical Center- Site Number : 840042 — Sacramento
- University of California at San Diego- Site Number : 840007 — San Diego
- University of California at San Francisco- Site Number : 840051 — San Francisco
Alabama
- University of Alabama Birmingham- Nephrology- Site Number : 840018 — Birmingham
- University of Alabama Birmingham- Nephrology- Site Number : 840073 — Birmingham
Arizona
- Phoenix Children's Hospital- Site Number : 840003 — Phoenix
- University of Arizona- Site Number : 840015 — Tucson
Arkansas
- Arkansas Children's Hospital- Site Number : 840109 — Little Rock
- University of Arkansas for Medical Sciences- Site Number : 840113 — Little Rock
Connecticut
- Yale University School of Medicine- Site Number : 840047 — New Haven
District of Columbia
- Children's National Medical Center - Washington- Site Number : 840067 — Washington D.C.
Florida
- University Hematology Oncology- Site Number : 840075 — Coral Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9,000 participants |
| Start Date | 2001-07-31 |
| Est. Completion | 2034-01-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00196742
The ClinicalTrials.gov registry entry for NCT00196742 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 9,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genzyme, a Sanofi Company, which has 52 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fabry Disease appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00196742 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00196742 about?
NCT00196742 is a clinical study titled "Fabry Disease Registry & Pregnancy Sub-registry". 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 an...
What is the current status of trial NCT00196742?
This trial is currently recruiting. The enrollment target is 9,000 participants. The study started on 2001-07-31. Estimated completion is 2034-01-31.
What conditions does trial NCT00196742 study?
This clinical trial studies the following conditions: Fabry Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT00196742?
This trial is sponsored by Genzyme, a Sanofi Company, which has 52 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00196742 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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