Mucopolysaccharidosis I (MPS I) Registry

StatusCompleted
PhaseNot specified
Started

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Record History

The 50 most recent of 105 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Completed
    • Enrollment target: estimated 1500 to confirmed 1406
    • Study sites: 180 to 141
    • Primary and study completion dates changed from estimate of Jan 31, 2034 to Dec 31, 2024
    v105
  2. Study sites revised (180)v104
  3. Study sites revised (180)v103
  4. Study sites: 143 to 180v102
  5. Study sites: 180 to 143v101
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 180 sitesv100
  2. Site details revised at 1 of 180 sitesv99
  3. Study sites revised (180)v98
  4. Study sites revised (180)v97
  5. Study sites: 179 to 180v96
  6. Site details revised at 2 of 179 sitesv95
  7. Study sites: 184 to 179v94
  8. Re-verified, no change to tracked fieldsv93
  9. Study sites: 187 to 184v92
  10. Study sites: 137 to 187v91
  11. Study sites: 136 to 137v90
  12. Study sites: 133 to 136v89
  13. Site details revised at 2 of 133 sitesv88
  14. Study sites: 130 to 133v87
  15. Re-verified, no change to tracked fieldsv86
  16. Study sites: 128 to 130v85
  17. 2 versions Re-verified since Sep 26, 2019, no change to tracked fieldsv83-v84
  18. Site details revised at 1 of 128 sitesv82
  19. Study sites: 123 to 128v81
  20. 2 versions Re-verified since May 3, 2019, no change to tracked fieldsv79-v80
  21. Primary and study completion dates: Dec 31, 2020 to Jan 31, 2034v78
  22. Study sites: 122 to 123v77
  23. Study Status, Referencesv76
  24. Re-verified, no change to tracked fieldsv75
  25. Study sites: 121 to 122v74
  26. Study sites: 119 to 121v73
  27. Re-verified, no change to tracked fieldsv72
  28. Study sites: 118 to 119v71
  29. Primary and study completion dates: Dec 31, 2021 to Dec 31, 2020v70
  30. Study sites: 117 to 118v69
  31. Study sites: 116 to 117v68
  32. Primary and study completion dates: Dec 31, 2020 to Dec 31, 2021v67
  33. Study sites: 115 to 116v66
  34. Study sites: 114 to 115v65
  35. Site details revised at 1 of 114 sitesv64
  36. Study sites: 109 to 114v63
  37. Study sites: 105 to 109v62
  38. Re-verified, no change to tracked fieldsv61
  39. Study sites: 103 to 105v60
  40. Study sites: 97 to 103v59
  41. Study sites: 80 to 97v58
  42. Primary and study completion dates: Sep 30, 2022 to Dec 31, 2020v57
  43. Study sites: 79 to 80v56
  • 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.
Sanofi
286 trials monitored
See 13 trials at risk
The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities. The objectives of the Registry are: * To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase) * To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I * To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care
Trial Details
NCT Number NCT00144794
Lead Sponsor Genzyme, a Sanofi Company
Conditions
(from sponsor)		 Mucopolysaccharidosis I (MPS I)
Related terms Mucopolysaccharidosis I
Enrollment 1,406 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov