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NCT03879135 · ClinicalTrials.gov registry record · Phase 3
A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)
A Phase 3 study of Von Willebrand Disease (VWD), sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
- 20
- Study locations
NCT03879135 is a Phase 3 study of Von Willebrand Disease (VWD) that has completed, run by Baxalta now part of Shire. The registered enrollment target is 38 participants, below the 100-participant average among 4 other Von Willebrand Disease (VWD) trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT03879135, a Phase 3 study of Von Willebrand Disease (VWD), has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment. The participants will be treated with rVWF for a maximum of 3 years. Their von Willebrand Disease will be treated according to Investigational product (IP) dosing directions.
Conditions Studied
Interventions
- BIOLOGICAL rVWF
- BIOLOGICAL rFVIII
Study Locations (20)
Other
- AKH - Medizinische Universität Wien - Vienna
- Groupement Hospitalier Est- Hôpital Louis Pradel - Bron
- Groupe Hospitalier Pellegrin - Hôpital Pellegrin - Gironde
- Groupement Hospitalier Sud - Hôpital Bicêtre - Le Kremlin-Bicêtre
- Klinikum der Johann Wolfgang Goethe-Universitaet - Frankfurt
- Werlhof-Institut GmbH - Hanover
- Azienda Ospedaliera Universitaria Careggi - Florence
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - Milan
- Azienda Ospedaliera Pediatrica Santobono Pausillipon - Naples
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Roma
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Rainbow Babies and Children's Hospital - Cleveland
- Nationwide Children's Hospital - Columbus
Arkansas
- Arkansas Children's Hospital Research Institute - Little Rock
Colorado
- University of Colorado Health - Aurora
Florida
- University of Florida College of Medicine - Gainesville
Indiana
- Indiana Hemophilia and Thrombosis Center - Indianapolis
South Carolina
- Medical University of South Carolina (MUSC) - Charleston
Nord
- Hopital Cardiologique - CHU Lille - Lille
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-04-01 |
| Est. Completion | 2025-01-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03879135
The ClinicalTrials.gov registry entry for NCT03879135 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 4 other Von Willebrand Disease (VWD) trials with a reported enrollment target (62% lower). The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Von Willebrand Disease (VWD) appearing as the primary indexed condition, and to 2 interventions - of which rVWF is the first listed.
NCT03879135 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, Ohio, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03879135 about?
NCT03879135 is a clinical study titled "A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD)". The main aim of the study is to check effectiveness of rVWF (vonicog alfa) prophylaxis based on the annualized bleeding rate (ABR) of spontaneous (not related to trauma) bleeding episodes in pediatric and adult participants during the first 12 months on study treatment. The participants will be tre...
What is the current status of trial NCT03879135?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2019-04-01. Estimated completion is 2025-01-30.
What conditions does trial NCT03879135 study?
This clinical trial studies the following conditions: Von Willebrand Disease (VWD).
What interventions are being tested in trial NCT03879135?
The interventions under investigation include: rVWF (BIOLOGICAL), rFVIII (BIOLOGICAL).
Who is sponsoring clinical trial NCT03879135?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03879135 being conducted?
This trial has 20 study locations across Arkansas, Colorado, Florida, Indiana, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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T-TAS® wS Method Comparison
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Read our methodology - how this data is sourced, computed, and verified.
Related
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