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A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease
NCT06998524 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Emicizumab
- DRUG von Willebrand Factor (VWF) Concentrates
- DRUG Factor VIII (FVIII) Concentrates
- DRUG von Willebrand Factor (VWF) and Factor VIII (FVIII) Concentrates
- DRUG Bypassing Agents
Study Locations (20)
Other
- UZ Leuven Gasthuisberg — Leuven
- IPS SURA Industriales Medellín — Medellín
- Hopital Claude Huriez - CHU Lille — Lille
- Groupe Hospitalier Necker Enfants Malades — Paris
- Universitätsklinikum Bonn — Bonn
- Gerinnungszentrum Rhein-Ruhr;Gerinnungsambulanz — Duisburg
- Hämophiliezentrum Med. Klinik III/Institut für Transfusionsmedizin — Frankfurt/M.
- Kurume University Hospital — Fukuoka
- Nagoya University Hospital — Nagoya
- Erasmus MC — Rotterdam
- Instytut Hematologii i Transfuzjologii — Warsaw
California
- UC Davis — Sacramento
Florida
- University of Florida — Gainesville
Minnesota
- University of Minnesota Medical Center — Minneapolis
Missouri
- Washington University School of Medicine — St Louis
Ontario
- The Hospital for Sick Children — Toronto
Quebec
- McGill University Health Center — Montreal
Lazio
- Universita' Degli Studi La Sapienza-Ist.Di Ematologia — Rome
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2025-06-27 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06998524
The ClinicalTrials.gov registry entry for NCT06998524 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Von Willebrand Disease, Type 3 appearing as the primary indexed condition, and to 5 interventions — of which Emicizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06998524 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06998524 about?
NCT06998524 is a clinical study titled "A Study to Assess the Efficacy and Safety of Emicizumab in Participants With Type 3 Von Willebrand Disease". 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 stan...
What is the current status of trial NCT06998524?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2025-06-27. Estimated completion is 2029-03-30.
What conditions does trial NCT06998524 study?
This clinical trial studies the following conditions: Von Willebrand Disease, Type 3. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06998524?
The interventions under investigation include: Emicizumab (DRUG), von Willebrand Factor (VWF) Concentrates (DRUG), Factor VIII (FVIII) Concentrates (DRUG), von Willebrand Factor (VWF) and Factor VIII (FVIII) Concentrates (DRUG), Bypassing Agents (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06998524?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06998524 being conducted?
This trial has 20 study locations across California, Florida, Minnesota, Missouri, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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