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Emicizumab for Severe Von Willebrand Disease (VWD) and VWD/Hemophilia A

Study acronym: BCDI-XII
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary completion date: Dec 2025 to Jun 2027
    • Study sites: 9 to 12
    • Study completion date: Jun 2027 to Feb 2028
    v4
  2. Study sites: 1 to 9v3 Show 5 more changesShow less
    • Primary completion date: Nov 2025 to Dec 2025
    • Study completion date: Mar 2026 to Jun 2027
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (3)
    • Study description revised
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2022 to Nov 1, 2022
    • Site details revised
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Von Willebrand Disease (VWD) is the most common inherited bleeding disorder affecting up to 0.1% of the population, is usually characterized by mucocutaneous bleeding, HMB, surgical bleeding or other hemostatic challenges. Severe bleeding events require VWF concentrates administered solely through intravenous access. Emicizumab (Hemlibra) is a monoclonal bispecific antibody developed to bind activated FIX and FX and mimic FVIII cofactor functionality. Hemlibra is administered via subcutaneous injection rather than intravenous infusion. The hypothesis of this study is that Emicizumab is safe and efficacious for prophylaxis in severe VWD and concomitant VWD/hemophilia patients.
Trial Details
NCT Number NCT05500807
Lead Sponsor Bleeding and Clotting Disorders Institute Peoria, Illinois
Collaborators: Genentech, Inc.
Conditions
(from sponsor)		 Von Willebrand Disease, Type 3, Concomitant VWD and Hemophilia
Related terms Hemophilia A, von Willebrand Disease, Type 3
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov