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NCT02283268 · ClinicalTrials.gov registry record · Phase 3
Recombinant Von Willebrand Factor in Subjects With Severe Von Willebrand Disease Undergoing Surgery
A Phase 3 study of Von Willebrand Disease, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
- 20
- Study locations
NCT02283268: Completed Phase 3 study of Von Willebrand Disease, sponsored by Baxalta now part of Shire.
NCT02283268 is a Phase 3 study of Von Willebrand Disease that has completed, run by Baxalta now part of Shire. The registered enrollment target is 24 participants, roughly in line with the 24-participant average among 3 other Von Willebrand Disease trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02283268, a Phase 3 study of Von Willebrand Disease, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Hemostatic efficacy will be rated on a scale of excellent - good - moderate - none. Excellent: Intra-, and postoperative hemostasis achieved with rVWF with our without ADVATE was as good or better than that expected for the type of surgical procedure performed in a hemostatically normal subject. Good: Intra-, and postoperative hemostasis achieved with rVWF with or without ADVATE was probably as good as that expected for the type of surgical procedure performed in a hemostatically normal subject.
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 |
What the finished NCT02283268 record still lists
NCT02283268 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, roughly in line with the 24-participant average among 3 other Von Willebrand Disease trials with a reported enrollment target.
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.
NCT02283268 names 20 study sites across 15 states, led by Other, Ohio, Western Australia.
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.
What interventions are being tested in trial NCT02283268?
The interventions under investigation include: Recombinant von Willebrand Factor (rVWF) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02283268?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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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