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Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
NCT02283268 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von Willebrand disease (VWD).
Conditions Studied
Interventions
- BIOLOGICAL Recombinant von Willebrand Factor (rVWF)
Study Locations (20)
Other
- AKH - Medizinische Universität Wien — Vienna
- Fakultni nemocnice Ostrava — Ostrava
- Azienda Ospedaliero - Universitaria Careggi — Firenze (Florence)
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico — Milan
Ohio
- Case Western Reserve University Hospital — Cleveland
- Cleveland Clinic — Cleveland
Western Australia
- The Perth Blood Institute — Nedlands
- Fiona Stanley Hospital — Perth
Colorado
- University of Colorado Hemophilia & Thrombosis Center — Aurora
Florida
- University of Miami, Jackson Memorial Hospital — Miami
Georgia
- Georgia Regents University — Augusta
Maryland
- John Hopkins University — Baltimore
Massachusetts
- Dana Farber Cancer Institute — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2016-07-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02283268
The ClinicalTrials.gov registry entry for NCT02283268 describes a study currently listed as completed. 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 Baxalta now part of Shire, which has 12 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 appearing as the primary indexed condition, and to 1 intervention — of which Recombinant von Willebrand Factor (rVWF) 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: NCT02283268 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Ohio, Western Australia. 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 NCT02283268 about?
NCT02283268 is a clinical study titled "Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery". The purpose of the study is to assess the efficacy and safety of recombinant von Willebrand factor (rVWF) with or without ADVATE in major and minor elective surgical procedures in adult patients with hereditary severe von Willebrand disease (VWD).
What is the current status of trial NCT02283268?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2015-04-01. Estimated completion is 2016-07-06.
What conditions does trial NCT02283268 study?
This clinical trial studies the following conditions: Von Willebrand Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02283268?
The interventions under investigation include: Recombinant von Willebrand Factor (rVWF) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02283268?
This trial is sponsored by Baxalta now part of Shire, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02283268 being conducted?
This trial has 20 study locations across Colorado, Florida, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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