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Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 30 to 31v40
  2. Study sites: 29 to 30v39
  3. Site details revised at 14 of 29 sitesv38
  4. Study sites revised (29)v37 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 5 of 29 sitesv36
Show 34 earlier versionsHide 34 earlier versions
  1. Primary and study completion dates: Oct 27, 2031 to Jun 10, 2031 Site details revised at 3 of 29 sitesv35 Show 1 more changeShow less
    • Site details revised at 3 of 29 sites
  2. Site details revised at 1 of 29 sitesv34
  3. Site details revised at 4 of 29 sitesv33
  4. Site contacts updated at 4 of 29 sitesv32
  5. Study sites revised (29)v31 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 28 to 29v30
  7. Re-verified, no change to tracked fieldsv29
  8. Study sites: 27 to 28v28
  9. Study sites: 26 to 27v27
  10. Site details revised at 1 of 26 sitesv26
  11. Study sites: 24 to 26v25
  12. Site details revised at 1 of 24 sitesv24
  13. Re-verified, no change to tracked fieldsv23
  14. Site details revised at 1 of 24 sitesv22
  15. Study sites: 22 to 24v21
  16. Study sites: 21 to 22v20
  17. Primary and study completion dates: Jan 15, 2029 to Oct 27, 2031 Study sites: 20 to 21v19 Show 1 more changeShow less
    • Study sites: 20 to 21
  18. Enrollment target: 71 to 130 Study description expanded, about 33 words · Site contacts updated at 1 of 20 sitesv18 Show 2 more changesShow less
    • Study description expanded, about 33 words
    • Site contacts updated at 1 of 20 sites

    See this version in full on ClinicalTrials.gov ↗

  19. Enrollment target: 130 to 71 Site details revised at 2 of 20 sitesv17 Show 1 more changeShow less
    • Site details revised at 2 of 20 sites
  20. Study sites: 19 to 20v16
  21. Study sites: 18 to 19 Primary and study completion dates: Jan 17, 2029 to Jan 15, 2029v15 Show 1 more changeShow less
    • Primary and study completion dates: Jan 17, 2029 to Jan 15, 2029
  22. Study sites: 17 to 18v14
  23. Study sites: 14 to 17v13
  24. Study sites: 11 to 14v12
  25. Study sites: 9 to 11v11
  26. Study sites: 8 to 9v10
  27. Study sites: 7 to 8v9
  28. Study sites: 6 to 7v8
  29. Study sites: 4 to 6v7
  30. Study sites: 2 to 4v6
  31. Study sites: 1 to 2v5
  32. Start date changed from estimate of Jun 15, 2021 to Jun 10, 2021v4
  33. Trial status: Not Yet Recruiting to Recruiting Start date: Apr 28, 2021 to Jun 15, 2021 · Primary endpoint revised · Study sites: 0 to 1 · 2 morev3 Show 5 more changesShow less
    • Start date: Apr 28, 2021 to Jun 15, 2021
    • Primary endpoint revised
    • Study sites: 0 to 1
    • Primary and study completion dates: Nov 30, 2028 to Jan 17, 2029
    • Secondary endpoints expanded, about 8 words

    See this version in full on ClinicalTrials.gov ↗

  34. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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.
Novartis
555 trials monitored
See 31 trials at risk
Sickle Cell Disease
357 trials monitored
See 25 trials at risk
This is a multi-center multi-national rollover study to allow continued access to crizanlizumab for patients with sickle cell disease (SCD) who are on crizanlizumab treatment in a Novartis-sponsored study (parent study) and are benefiting from the treatment as judged by the investigator.
Trial Details
NCT Number NCT04657822
Lead Sponsor Novartis Pharmaceuticals
Conditions Sickle Cell Disease
Enrollment 130 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov