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A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD)
NCT05582993 · View on ClinicalTrials.gov ↗
Study Summary
The main aim of the study is to evaluate the effectiveness of prophylaxis with vonicog alfa (recombinant von Willebrand factor \[rVWF\]) in children. This study will enroll those participants who have been previously treated with VWF product or with a plasma-derived VWF (pdVWF) product. In this study, participants will be treated with vonicog alfa (rVWF) for 12 months. During the study, participants will visit the study clinic 5 times after treatment initiation.
Conditions Studied
Interventions
- BIOLOGICAL Vonicog Alfa
- BIOLOGICAL ADVATE
Study Locations (15)
Other
- Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est) Bureau 419 — Lille
- Hopital Edouard Herriot - CHU Lyon — Lyon
- Children's Health Ireland — Dublin
- Azienda Ospedaliera Pediatrica Santobono Pausillipon — Naples
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino — Turin (Torino)
- Nara Medical University Hospital — Kashihara
Alabama
- University of Alabama at Birmingham — Birmingham
Illinois
- Bleeding and Clotting Disorders Institute — Peoria
Indiana
- Riley Hospital for Children Indiana University Health — Indianapolis
Iowa
- University of Iowa Hospitals & Clinics PARENT — Iowa City
Michigan
- Childrens Hospital of Michigan — Detroit
Minnesota
- Children's Health Care d/b/a Children's Minnesota — Minneapolis
New Jersey
- Rutgers - Robert Wood Johnson Medical School — New Brunswick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2024-11-06 |
| Est. Completion | 2030-04-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05582993
The ClinicalTrials.gov registry entry for NCT05582993 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 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 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 (VWD) appearing as the primary indexed condition, and to 2 interventions — of which Vonicog Alfa 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: NCT05582993 reports 15 study locations spanning 10 distinct geographic areas — top geographies include Other, Alabama, Illinois. 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 NCT05582993 about?
NCT05582993 is a clinical study titled "A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD)". The main aim of the study is to evaluate the effectiveness of prophylaxis with vonicog alfa (recombinant von Willebrand factor \[rVWF\]) in children. This study will enroll those participants who have been previously treated with VWF product or with a plasma-derived VWF (pdVWF) product. In this stud...
What is the current status of trial NCT05582993?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2024-11-06. Estimated completion is 2030-04-11.
What conditions does trial NCT05582993 study?
This clinical trial studies the following conditions: Von Willebrand Disease (VWD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05582993?
The interventions under investigation include: Vonicog Alfa (BIOLOGICAL), ADVATE (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05582993?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05582993 being conducted?
This trial has 15 study locations across Alabama, Illinois, Indiana, Iowa, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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