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Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX

Study acronym: ATLAS-OLE
StatusCompleted
PhasePhase 3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Nov 5, 2026 to Sep 14, 2026
    • Eligibility criteria expanded, about 13 words
    • Site details revised at 3 of 79 sites
    • Publications: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv45
  3. Secondary endpoints: details revised at 1 of 4 entries
    • Study description expanded, about 1 word
    v44
  4. Re-verified, no change to tracked fieldsv43
  5. Enrollment target: 355 to 281
    • Primary and study completion dates: Dec 18, 2026 to Nov 5, 2026
    • Study sites revised (79)
    v42
Show 40 earlier versionsHide 40 earlier versions
  1. Primary and study completion dates: Oct 19, 2026 to Dec 18, 2026
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description shortened, about 63 words
    v41
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 244 to confirmed 355
    • Site details revised at 79 of 79 sites
    v40
  3. Study sites: 77 to 79v39
  4. Primary endpoint revisedv38 Show 4 more changesShow less
    • Primary and study completion dates: Oct 2026 to Oct 19, 2026
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 36 words
  5. Study sites: 59 to 77v37
  6. Primary and study completion dates: Jan 2026 to Oct 2026v36
  7. Site details revised at 9 of 59 sitesv35
  8. Site details revised at 2 of 59 sitesv34
  9. Secondary endpoints: details revised at 1 of 4 entries
    • Study description revised
    v33
  10. Study sites: 44 to 59v32
  11. Site details revised at 2 of 44 sitesv31
  12. Study sites: 45 to 44v30
  13. Study sites: 39 to 45v29
  14. Study sites: 35 to 39v28
  15. Study sites: 29 to 35v27
  16. Study sites: 32 to 29v26
  17. Primary and study completion dates: Oct 2025 to Jan 2026v25
  18. Study sites: 31 to 32v24
  19. Study sites: 30 to 31v23
  20. Study sites: 27 to 30v22
  21. Study sites: 25 to 27v21
  22. Study sites: 24 to 25v20
  23. Study sites: 22 to 24v19
  24. Study sites: 21 to 22v18
  25. Site details revised at 1 of 21 sitesv17
  26. Study sites: 20 to 21v16
  27. Study sites: 19 to 20v15
  28. Study sites: 18 to 19v14
  29. Study sites: 16 to 18v13
  30. Primary and study completion dates: Dec 2024 to Oct 2025v12
  31. Study sites: 6 to 16v11
  32. Re-verified, no change to tracked fieldsv10
  33. Primary and study completion dates: Oct 2024 to Dec 2024v9
  34. Study sites: 5 to 6v8
  35. Study sites: 4 to 5v7
  36. Re-verified, no change to tracked fieldsv6
  37. Study sites: 3 to 4v5
  38. Study sites: 2 to 3v4
  39. Study sites: 1 to 2v3
  40. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 15, 2019 to Jan 9, 2019
    v2
  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.
Sanofi
284 trials monitored
See 12 trials at risk
Hemophilia
241 trials monitored
See 12 trials at risk
Primary Objective: To characterize the long-term safety and tolerability of fitusiran Secondary Objectives: * To characterize the efficacy and long-term efficacy of fitusiran as assessed by the frequency of: * Bleeding episodes * Spontaneous bleeding episodes * Joint bleeding episodes * To characterize the effects of fitusiran on health-related quality of life (HRQOL) measures in participants ≥17 years of age
Trial Details
NCT Number NCT03754790
Lead Sponsor Genzyme, a Sanofi Company
Conditions
(from sponsor)		 Hemophilia
Related terms Hemophilia A
Enrollment 281 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov