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SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 12, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 22 to 21v30
  2. Study sites: 23 to 22v29
  3. Study sites: 24 to 23v28
  4. Site contacts updated at 1 of 24 sitesv27
  5. Primary completion date: Nov 30, 2024 to Sep 30, 2026
    • Study sites: 26 to 24
    • Study completion date: Jun 1, 2025 to Mar 31, 2027
    • Study description expanded, about 27 words
    v26
Show 24 earlier versionsHide 24 earlier versions
  1. Site details revised at 1 of 26 sitesv25
  2. Site details revised at 1 of 26 sitesv24
  3. Site contacts updated at 1 of 26 sitesv23
  4. Study sites: 25 to 26v22
  5. Study sites: 26 to 25v21
  6. Site contacts updated at 2 of 26 sitesv20
  7. Site details revised at 1 of 26 sitesv19
  8. Primary completion date: Oct 31, 2023 to Nov 30, 2024
    • Site contacts updated at 2 of 26 sites
    v18
  9. Site details revised at 1 of 26 sitesv17
  10. Study sites: 25 to 26v16
  11. Study sites: 24 to 25v15
  12. Site details revised at 4 of 24 sitesv14
  13. Study sites: 21 to 24
    • Eligibility criteria shortened, about 1 word
    • Study description shortened, about 1 word
    v13
  14. Study sites: 22 to 21v12
  15. Study sites: 23 to 22v11
  16. Site details revised at 2 of 23 sitesv10
  17. Study sites: 19 to 23v9
  18. Site details revised at 1 of 19 sitesv8
  19. Site details revised at 1 of 19 sitesv7
  20. Study sites: 18 to 19v6
  21. Study sites: 1 to 18v5
  22. Trial status: Active, Not Recruiting to Recruiting
    • Start date: Apr 14, 2021 to Jun 28, 2021
    • Site details revised
    v4
  23. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 7 to 1
    v3
  24. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary endpoint revised
    • Study sites: 0 to 7
    • Study completion date: Jan 31, 2024 to Jun 1, 2025
    • Start date changed from estimate of Mar 31, 2021 to Apr 14, 2021
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.
Trial Details
NCT Number NCT04647227
Lead Sponsor American Thrombosis and Hemostasis Network
Collaborators: LFB USA, Inc.
Conditions
(from sponsor)		 Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
Related terms Hemophilia A, Hemophilia B
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov