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A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease

Study acronym: WILL-EMI
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 17 words Site details revised at 5 of 29 sites Show 1 more changeShow less
    • Site details revised at 5 of 29 sites
  2. Study sites: 28 to 29v19
  3. Re-verified, no change to tracked fieldsv18
  4. Study sites: 27 to 28v17
  5. Study Status, Contacts/Locations, Referencesv16
  6. Primary completion pushed from Mar 30, 2027 to Apr 30, 2027 Completion pushed from Mar 30, 2029 to Apr 30, 2029v15 Show 1 more changeShow less
    • Completion pushed from Mar 30, 2029 to Apr 30, 2029
  7. 2 versions Re-verified since Mar 18, 2026, no change to tracked fieldsv13-v14
  8. Study sites: 26 to 27v12
  9. Study sites: 24 to 26v11
  10. Study sites: 21 to 24 Primary completion date: Dec 31, 2026 to Mar 30, 2027 · Completion date: Dec 31, 2028 to Mar 30, 2029v10 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2026 to Mar 30, 2027
    • Completion date: Dec 31, 2028 to Mar 30, 2029
  11. Study sites: 20 to 21v9
  12. Study sites: 16 to 20v8
  13. Enrollment target: 66 to 75 Study sites: 13 to 16 · Primary completion date: Dec 15, 2027 to Dec 31, 2026 · Eligibility criteria expanded, about 22 words · 1 morev7 Show 4 more changesShow less
    • Study sites: 13 to 16
    • Primary completion date: Dec 15, 2027 to Dec 31, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: 23 to 25

    See this version in full on ClinicalTrials.gov ↗

  14. Study sites: 12 to 13v6
  15. Study sites: 9 to 12v5
  16. Study sites: 7 to 9v4
  17. Study sites: 1 to 7 Completion date: May 15, 2029 to Dec 31, 2028 · Start date changed from estimate of Jun 15, 2025 to Jun 27, 2025v3 Show 2 more changesShow less
    • Completion date: May 15, 2029 to Dec 31, 2028
    • Start date changed from estimate of Jun 15, 2025 to Jun 27, 2025
  18. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  19. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Roche/Genentech
366 trials monitored
See 33 trials at risk
This is a Phase III, multicenter, open-label clinical study designed to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of emicizumab prophylaxis in participants aged 1 month and above, who have been diagnosed with Type 3 von Willebrand disease (VWD). Participants on prior standard of care (SOC) on-demand therapy will be assessed via a randomized comparison (Arm A - emicizumab prophylaxis and Arm B - continuation of SOC on-demand therapy), while participants on prior SOC prophylactic therapy (Arm C - emicizumab prophylaxis) will be assessed via intra-participant analysis with data obtained from the preceding non-interventional study (NIS), WP45335 (NCT06883240).
Trial Details
NCT Number NCT06998524
Lead Sponsor Hoffmann-La Roche
Conditions Von Willebrand Disease, Type 3
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov