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Mucopolysaccharidosis I (MPS I) Registry

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

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, 2024v105 Show all 4 changesShow less
    • 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
  2. Study sites revised (180)v104 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites revised (180)v103 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  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 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites revised (180)v97 Show moreShow less

    See this version in full on ClinicalTrials.gov ↗

  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
  • 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.
Sanofi
284 trials monitored
See 12 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 Mucopolysaccharidosis I (MPS I)
Enrollment 1,406 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov