Pompe Disease Registry Protocol

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Study sites revised (272)v50
  2. Study sites: 271 to 272v49
  3. Study sites: 272 to 271v48
  4. Site details revised at 2 of 272 sitesv47
  5. Study sites: 271 to 272v46
Show 44 earlier versionsHide 44 earlier versions
  1. Study sites revised (271)v45
  2. Study sites: 275 to 271v44
  3. Study sites revised (275)v43
  4. Study sites: 212 to 275v42
  5. Study sites: 275 to 212v41
  6. Study sites revised (275)v40
  7. Site details revised at 1 of 275 sitesv39
  8. Site details revised at 1 of 275 sitesv38
  9. Study sites revised (275)v37
  10. Study sites revised (275)v36
  11. Study sites: 274 to 275v35
  12. Site details revised at 2 of 274 sitesv34
  13. Site details revised at 1 of 274 sitesv33
  14. Study sites: 272 to 274v32
  15. Study sites: 270 to 272v31
  16. Study sites: 191 to 270v30
  17. Eligibility criteria expanded, about 27 words
    • Study description expanded, about 7 words
    • Study title expanded, about 1 word
    v29
  18. Study sites: 190 to 191
    • Start date: Aug 21, 2004 to Sep 15, 2004
    v28
  19. Study sites: 50 to 190v27
  20. Primary and study completion dates: Sep 30, 2022 to Jan 31, 2034v26
  21. Publications: 2 to 5v25
  22. Primary and study completion dates: Sep 30, 2026 to Sep 30, 2022v24
  23. Primary and study completion dates: Sep 2022 to Sep 30, 2026
    • Start date: Sep 2004 to Aug 21, 2004
    v23
  24. Primary and study completion dates: Sep 2021 to Sep 2022v22
  25. Study sites: 1 to 50v21
  26. Re-verified, no change to tracked fieldsv20
  27. Eligibility criteria expanded, about 2 wordsv19
  28. Study description shortened, about 46 wordsv18
  29. Re-verified, no change to tracked fieldsv17
  30. Enrollment target: 2000
    • Primary and study completion dates: Sep 2021
    v16
  31. Study description shortened, about 1 wordv15
  32. Eligibility criteria shortened, about 4 wordsv14
  33. 3 versions Re-verified since Jul 31, 2009, no change to tracked fieldsv11-v13
  34. Enrollment target: 99999 to not statedv10
  35. Re-verified, no change to tracked fieldsv9
  36. Enrollment target: 99999v8
  37. 3 versions Re-verified since Jun 28, 2007, no change to tracked fieldsv5-v7
  38. Study sites: 5 to 1
    • Study description expanded, about 47 words
    v4
  39. Re-verified, no change to tracked fieldsv3
  40. Study title expanded, about 1 wordv2
  1. Study First Submitted
  • 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 Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. The objectives of the Registry are: * To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * To characterize the Pompe disease population. * To evaluate the long-term effectiveness of alglucosidase alfa.
Trial Details
NCT Number NCT00231400
Lead Sponsor Genzyme, a Sanofi Company
Conditions
(from sponsor)		 Glycogen Storage Disease Type II, Pompe Disease
Related terms Glycogen Storage Disease Type II
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov