29
Participants
Start Date
November 16, 2017
Primary Completion Date
July 6, 2020
Study Completion Date
July 6, 2020
von Willebrand factor (Recombinant)
OD participants will receive intravenous (IV) rVWF:RCo at an initial prophylactic dose of 50 +/- 10 International Unit per Kilogram (IU/kg) twice (two infusions) a week for at least 12 months up to 15 months and may be increased up to 80 IU/kg. pdVWF switch cohort participants will receive rVWF:RCo equivalent (± 10%) to the weekly VWF dose received during prophylactic treatment with pdVWF.
Antihemophilic Factor (Recombinant)
During prophylaxis period any bleeding episodes requiring substitution therapy with VWF concentrate to control bleeding will be treated with rVWF with or without ADVATE. Participants will receive rFVIII IV if necessary for OD treatment of breakthrough bleeds or for peri-operative. The dose will be according to the bleeding type and severity and it will be adjusted to the clinical response.
CHU CAEN - Hôpital de la Côte de Nacre, Caen
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan
CHU Dijon - Hopital du Bocage, Dijon
Comprehensive Cancer Center of Wake Forest Unversity, Winston-Salem
Hospital Universitario La Paz, Madrid
Hôpital Morvan, Brest
Werlhof-Institut GmbH, Hanover
Medizinische Hochschule Hannover, Hanover
University of Florida College of Medicine, Gainesville
University of Florida College of Medicine, Jacksonville
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul
Ege University Medical Faculty, Izmir
Ege University Medical Faculty, Izmir
Hospital Universitari i Politecnic La Fe, Valencia
Indiana Hemophilia and Thrombosis Center, Indianapolis
Coagulation Research Centre GmbH, Duisburg
Henry Ford Hospital, Detroit
Azienda Ospedaliera Universitaria Careggi, Florence
Ondokuz Mayis Univ. Med. Fac., Samsun
Hopital Cardiologique - CHU Lille, Lille
Klinikum der Johann Wolfgang Goethe-Universitaet, Frankfurt
Bleeding and Clotting Disorders Institute, Peoria
Groupement Hospitalier Est- Hôpital Louis Pradel, Bron
University of Colorado Health, Loveland
University of Colorado Health, Aurora
"FSBI of Science Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA", Kirov
"FSBI of Science Kirov Scientific and Research Institute of Hematology and Blood Transfusion of FMBA", Kirov
"SAIH Kemerovo Regional Clinical Hospital", Kemerovo
SBEI HPE Altai State Medical University of MoH and SD, Barnaul
Hamilton Health Sciences Centre, Hamilton
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Roma
Ospedale Pediatrico Bambino Gesù, Roma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma
Erasmus Medisch Centrum, Rotterdam
Hospital General Universitario de Alicante, Alicante
Lead Sponsor
Baxalta Innovations GmbH, now part of Shire
INDUSTRY
Takeda
INDUSTRY