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Fabry Disease Registry & Pregnancy Sub-registry

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 62 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor Eligibility criteria expanded, about 6 words
    • Study sites revised (284)
    • Publications: details revised at 7 of 7 entries
  2. Minor Study sites: 283 to 284v61
  3. Minor Study sites: 282 to 283v60
  4. Minor Study sites: 283 to 282v59
  5. Minor Study sites: 282 to 283v58
Show 45 earlier versionsHide 45 earlier versions
  1. Minor Study sites: 281 to 282v57
  2. Minor Site details revised at 2 of 281 sitesv56
  3. Minor Study sites: 280 to 281v55
  4. Minor Study sites: 277 to 280v54
  5. Minor Study sites: 276 to 277v53
  6. Minor Study sites: 282 to 276v52
  7. Minor Study sites revised (282)v51
  8. Minor Study sites: 272 to 282v50
  9. Minor Study sites: 282 to 272v49
  10. Minor Study sites revised (282)v48
  11. Minor Study sites: 281 to 282v47
  12. Minor Site details revised at 2 of 281 sitesv46
  13. Minor Study sites: 279 to 281v45
  14. Minor Study sites revised (279)v44
  15. Minor Study sites revised (279)v43
  16. Minor Study sites: 277 to 279v42
  17. Minor Study sites: 276 to 277v41
  18. Minor Study sites: 295 to 276v40
  19. Minor Study sites: 288 to 295v39
  20. Minor Study sites: 219 to 288v38
  21. Notable Primary endpoints: 1 to 2v37 Show 4 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints expanded, about 12 words
    • Study description shortened, about 46 words
    • Study title expanded, about 3 words
  22. Minor Study sites: 203 to 219v36
  23. Notable Primary and study completion dates: Jul 30, 2021 to Jan 31, 2034v35
  24. Minor Publications: 4 to 7v34
  25. Minor Primary and study completion dates: Dec 31, 2021 to Jul 30, 2021v33
  26. Minor Primary and study completion dates: Jul 30, 2021 to Dec 31, 2021v32
  27. Minor Study sites: 64 to 203v31
  28. Notable Primary and study completion dates: Sep 2022 to Jul 30, 2021v30
  29. Notable Primary and study completion dates: Jul 30, 2021 to Sep 2022v29
  30. Notable Primary and study completion dates: Jan 30, 2030 to Jul 30, 2021v28
  31. Notable Primary and study completion dates: Jul 2021 to Jan 30, 2030
    • Start date: Jul 2001 to Jul 31, 2001
    v27
  32. Notable Primary and study completion dates: Jul 2030 to Jul 2021v26
  33. Notable Primary and study completion dates: Jul 2021 to Jul 2030v25
  34. Notable Primary and study completion dates: Jul 2030 to Jul 2021v24
  35. Minor Study sites: 1 to 64v23
  36. Minor Primary and study completion dates: Jan 2030 to Jul 2030v22
  37. Notable Primary and study completion dates: Jul 2020 to Jan 2030
    • Start date: Apr 2001 to Jul 2001
    v21
  38. Minor Re-verified, no change to tracked fieldsv20
  39. Minor Eligibility criteria expanded, about 1 wordv19
  40. Minor Re-verified, no change to tracked fieldsv18
  41. Minor Enrollment target: 9000
    • Primary and study completion dates: Jul 2020
    • Eligibility criteria expanded, about 12 words
    v17
  42. Minor Study description shortened, about 1 wordv16
  43. Minor 2 versions Re-verified since Dec 8, 2011, no change to tracked fieldsv14-v15
  44. Minor Study Status, Arms and Interventionsv13
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
284 trials monitored
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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.
Trial Details
NCT Number NCT00196742
Lead Sponsor Genzyme, a Sanofi Company
Conditions
(from sponsor)
Fabry Disease
Related terms Angiokeratoma, Fabry Disease
Enrollment 9,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov