International Collaborative Gaucher Group (ICGG) Gaucher Disease Registry & Pregnancy Sub-registry

StatusRecruiting
PhaseNot specified
Started

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Record History

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  1. Minor Study sites: 318 to 317
    • Publications: details revised at 8 of 8 entries
    • Eligibility criteria expanded, about 5 words
  2. Minor Study sites revised (318)v40
  3. Minor Study sites: 319 to 318v39
  4. Minor Study sites: 318 to 319v38
  5. Minor Study sites: 315 to 318v37
Show 35 earlier versionsHide 35 earlier versions
  1. Minor Study sites revised (315)v36
  2. Minor Study sites: 299 to 315v35
  3. Minor Study sites: 314 to 299
    • Start date: Apr 1991 to Apr 1, 1991
    v34
  4. Minor Site details revised at 1 of 314 sitesv33
  5. Minor Site details revised at 1 of 314 sitesv32
  6. Minor Study sites revised (314)v31
  7. Minor Study sites revised (314)v30
  8. Minor Study sites: 311 to 314v29
  9. Minor Study sites: 310 to 311v28
  10. Minor Site details revised at 2 of 310 sitesv27
  11. Minor Study sites: 308 to 310v26
  12. Minor Study sites: 221 to 308v25
  13. Notable Primary endpoints: 1 to 2
    • Eligibility criteria expanded, about 38 words
    • Study title expanded, about 4 words
    v24
  14. Notable Primary and study completion dates: Jan 31, 2030 to Jan 31, 2034
    • Study sites: 63 to 221
    v23
  15. Minor Publications: 6 to 8v22
  16. Minor Primary and study completion dates: Jan 2030 to Jan 31, 2030v21
  17. Minor Study sites: 1 to 63v20
  18. 2 versions Re-verified since Aug 26, 2014, no change to tracked fieldsv18-v19
  19. Minor Study description shortened, about 47 wordsv17
  20. Re-verified, no change to tracked fieldsv16
  21. Minor Enrollment target: 12000
    • Primary and study completion dates: Jan 2030
    v15
  22. Minor Study description shortened, about 1 wordv14
  23. 4 versions Re-verified since Jul 30, 2009, no change to tracked fieldsv10-v13
  24. Minor Enrollment target: 99999 to not statedv9
  25. Minor Enrollment target: 99999v8
  26. Re-verified, no change to tracked fieldsv7
  27. Study Status, Study Design, Eligibilityv6
  28. Minor Eligibility criteria expanded, about 1 word
    • Study description expanded, about 1 word
    • Study title expanded, about 2 words
    v5
  29. Minor Start date: Nov 2001 to Apr 1991v4
  30. Minor Study description revisedv3
  31. Minor Study description shortened, about 290 words
    • Study site revised
    v2
  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.
285 trials monitored
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The ICGG Gaucher Registry is an ongoing, international multi-center, strictly observational program that tracks the routine clinical outcomes for patients with Gaucher 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 objectives of the Registry are: * To enhance understanding of the variability, progression, identification, and natural history of Gaucher disease, with the ultimate goal of better guiding and assessing therapeutic intervention. * To assist the Gaucher medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. * To characterize the Gaucher disease population. * To evaluate the long-term effectiveness of imiglucerase and of eliglustat. Gaucher Pregnancy Sub-registry: The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Gaucher disease during pregnancy, regardless of whether they receive disease-specific therapy. 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 NCT00358943
Lead Sponsor Genzyme, a Sanofi Company
Conditions
(from sponsor)
Gaucher Disease, Cerebroside Lipidosis Syndrome, Glucocerebrosidase Deficiency Disease, Glucosylceramide Beta-Glucosidase Deficiency Disease
Related terms Gaucher Disease
Enrollment 12,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov