A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis

Study acronym: Beyond ABR
StatusActive, Not Recruiting
PhasePhase 4
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 4, 2026 → Nov 30, 2027
See other at-risk trials from Roche/Genentech

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion dates pushed to Nov 30, 2027v43
  2. 2 versions Re-verified since Apr 23, 2026, no change to tracked fieldsv41-v42
  3. Minor Study sites: 27 to 28v40
  4. Re-verified, no change to tracked fieldsv39
  5. Minor Study sites revised (27)v38
Show 36 earlier versionsHide 36 earlier versions
  1. Minor Study sites revised (27)v37
  2. Minor Primary completion date: Dec 28, 2026 to Dec 4, 2026
    • Study completion date: Dec 28, 2026 to May 21, 2027
    v36
  3. Minor Study sites: 28 to 27v35
  4. 3 versions Re-verified since May 13, 2024, no change to tracked fieldsv32-v34
  5. Minor Study sites: 29 to 28v31
  6. Minor Enrollment target: estimated 120 to confirmed 136
    • Study sites: 31 to 29
    v30
  7. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 34 to 31
    v29
  8. Minor Study sites: 30 to 34v28
  9. Minor Site details revised at 4 of 30 sitesv27
  10. Minor Study sites: 28 to 30v26
  11. Minor Site details revised at 1 of 28 sitesv25
  12. Minor Study sites: 27 to 28
    • Eligibility criteria expanded, about 4 words
    v24
  13. Minor Site details revised at 1 of 27 sitesv23
  14. Minor Study sites: 25 to 27
    • Primary and study completion dates: Oct 17, 2026 to Dec 28, 2026
    v22
  15. Minor Study sites: 24 to 25v21
  16. Minor Study sites: 23 to 24v20
  17. Minor Study sites: 22 to 23v19
  18. Minor Study sites revised (22)v18
  19. Minor Site details revised at 2 of 22 sitesv17
  20. Minor Study sites: 20 to 22v16
  21. Minor Study sites: 18 to 20v15
  22. Minor Study sites: 14 to 18v14
  23. Minor Study sites: 12 to 14v13
  24. Minor Study sites: 11 to 12v12
  25. Minor Study sites: 9 to 11v11
  26. Minor Study sites: 7 to 9v10
  27. Minor Study sites: 6 to 7
    • Start date changed from estimate of Jul 31, 2022 to Jun 20, 2022
    v9
  28. Minor Study sites: 3 to 6
    • Eligibility criteria expanded, about 15 words
    v8
  29. Notable Start date: May 31, 2022 to Jul 31, 2022v7
  30. Notable Start date: Apr 30, 2022 to May 31, 2022
    • Study sites: 1 to 3
    v6
  31. Re-verified, no change to tracked fieldsv5
  32. Notable Start date: Feb 28, 2022 to Apr 30, 2022v4
  33. Re-verified, no change to tracked fieldsv3
  34. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 13 to 1
    • Start date: Jan 31, 2022 to Feb 28, 2022
    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.
369 trials monitored
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242 trials monitored
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Study MO42623 is a Phase IV, multicenter, open-label, three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants aged ≥13 and \<70 years with severe hemophilia A without factor VIII (FVIII) inhibitors or moderate hemophilia A without FVIII inhibitors who are receiving FVIII prophylaxis and who will start emicizumab treatment as part of this study.
Trial Details
NCT Number NCT05181618
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)
Severe Hemophilia A, Moderate Hemophilia A
Related terms Hemophilia A
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov