16
Participants
Start Date
December 8, 2017
Primary Completion Date
May 4, 2020
Study Completion Date
February 16, 2021
rFVIIIFc
rFVIIIFc 200 IU/kg/day in ITI Period, 50 or 100 IU/kg (adjusted according to Investigator judgement) in tapering Period, and prophylactic regimen in Follow-Up period as powder for injection administered intravenously.
Cliniques Universitaires Saint-Luc, Brussels
UMHAT 'Tsaritsa Yoanna - ISUL', EAD, Sofia
UZ Leuven, Leuven
"UMHAT Sv. Georgi, EAD", Plovdiv
Hospital Universitari Vall d'Hebron, Barcelona
Hôpital de la Timone, Marseille
Children's National Medical Center, Washington D.C.
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Milan
CHU Besançon - Hôpital Jean Minjoz, Besançon
Hospital Universitario La Paz, Madrid
CHU de Toulouse - Hôpital Purpan, Toulouse
Ospedale San Bortolo di Vicenza, Vicenza
Dayton Children's Hospital, Dayton
Hospital Universitari i Politecnic La Fe, Valencia
Indiana Hemophilia and Thrombosis Center, Indianapolis
Childrens Hospital of Michigan, Detroit
University of Iowa Children's Hospital, Iowa City
Universitaetsklinikum Bonn AoeR, Bonn
Blood Center of Southeast Wisconsin, Milwaukee
Hemostase Clinique - Institut Cœur-Poumons (4eme étage aile est), Lille
Rush University Medical Center, Chicago
Hôpital Necker - Enfants Malades, Paris
Cook Children's Medical Center, Fort Worth
Gulf States Hemophilia and Thrombophilia Center, Houston
El Paso Children's Hospital, El Paso
University of Colorado Hemophilia & Thrombosis Center, Aurora
Azienda Ospedaliera Pediatrica Santobono Pausillipon, Napoli
Center for Inherited Blood Disorders, Orange
Children's & Women's Health Centre of British Columbia, Vancouver
McMaster Children's Hospital, Hamilton
The Hospital for Sick Children, Toronto
Nagoya University Hospital, Nagoya
St. Marianna University School of Medicine Hospital, Kawasaki
Nara Medical University Hospital, Kashihara-shi
St Thomas' Hospital, London
John Radcliffe Hospital, Oxford
Royal Hospital for Children, Glasgow
Collaborators (1)
Swedish Orphan Biovitrum
INDUSTRY
Bioverativ, a Sanofi company
INDUSTRY