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NCT02973087 · ClinicalTrials.gov registry record · Phase 3
rVWF IN PROPHYLAXIS
A Phase 3 study of Von Willebrand Disease, sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 29
- Enrollment target
- 20
- Study locations
NCT02973087: Completed Phase 3 study of Von Willebrand Disease, sponsored by Takeda.
NCT02973087 is a Phase 3 study of Von Willebrand Disease that has completed, run by Takeda. The registered enrollment target is 29 participants, above the 23-participant average among 3 other Von Willebrand Disease trials with a reported enrollment target (26% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02973087, a Phase 3 study of Von Willebrand Disease, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 29 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebrand factor (rVWF) (vonicog alfa) in adult participants with severe von Willebrand disease (VWD).
Primary Outcome
ABR for treated spontaneous BEs while on prophylactic treatment with rVWF through month 12 of treatment period/observation period (in years), where an observation period = (date of completion/termination - date of first dose + 1)/365.2425. Bleeds occurred at the same anatomical location with the same etiology within 24 hours after onset of the first bleed were considered a single bleed. Bleeding occurred at multiple locations related to the same injury were considered as a single bleeding episod
Conditions Studied
Interventions
- BIOLOGICAL Antihemophilic Factor (Recombinant)
- BIOLOGICAL von Willebrand factor (Recombinant)
Study Locations (20)
Other
- Hamilton Health Sciences Centre - Hamilton
- Groupement Hospitalier Est- Hôpital Louis Pradel - Bron
- CHU CAEN - Hôpital de la Côte de Nacre - Caen
- CHU Dijon - Hopital du Bocage - Dijon
- Hopital Cardiologique - CHU Lille - Lille
- Coagulation Research Centre GmbH - Duisburg
- Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt
- Werlhof-Institut GmbH - Hanover
- Medizinische Hochschule Hannover - Hanover
- Azienda Ospedaliera Universitaria Careggi - Florence
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - Milan
Florida
- University of Florida College of Medicine - Gainesville
- University of Florida College of Medicine - Jacksonville
Indiana
- University of Colorado Health - Aurora
- Indiana Hemophilia and Thrombosis Center - Indianapolis
Colorado
- University of Colorado Health - Loveland
Illinois
- Bleeding and Clotting Disorders Institute - Peoria
Michigan
- Henry Ford Hospital - Detroit
North Carolina
- Comprehensive Cancer Center of Wake Forest Unversity - Winston-Salem
Finistere
- Hôpital Morvan - Brest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2017-11-16 |
| Est. Completion | 2020-07-06 |
| Phase | Phase 3 |
What the finished NCT02973087 record still lists
NCT02973087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, above the 23-participant average among 3 other Von Willebrand Disease trials with a reported enrollment target (26% higher).
The record links to 1 condition, with Von Willebrand Disease appearing as the primary indexed condition, and to 2 interventions - of which Antihemophilic Factor (Recombinant) is the first listed.
NCT02973087 names 20 study sites across 8 states, led by Other, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT02973087 about?
NCT02973087 is a clinical study titled "rVWF IN PROPHYLAXIS". The purpose of this phase 3 study is to investigate the efficacy and safety, including immunogenicity, thrombogenicity and hypersensitivity reactions, as well as pharmacokinetics (PK), health related quality of life (HRQoL) and pharmacoeconomics of prophylactic treatment with recombinant von Willebr...
What is the current status of trial NCT02973087?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 29 participants. The study started on 2017-11-16. Estimated completion is 2020-07-06.
What conditions does trial NCT02973087 study?
This clinical trial studies the following conditions: Von Willebrand Disease.
What interventions are being tested in trial NCT02973087?
The interventions under investigation include: Antihemophilic Factor (Recombinant) (BIOLOGICAL), von Willebrand factor (Recombinant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02973087?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02973087 being conducted?
This trial has 20 study locations across Colorado, Florida, Illinois, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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