48
Participants
Start Date
January 30, 2017
Primary Completion Date
December 15, 2017
Study Completion Date
June 29, 2022
Emicizumab
Emicizumab will be administered according to dose and schedule described in respective arms. After at least 24 weeks on prophylactic emicizumab, individuals who experienced suboptimal bleeding control on emicizumab (according to protocol-defined criteria) had the opportunity to increase their dose to 3 mg/kg weekly. Upon implementation of protocol Version 5 (20-Dec-2019), treatment duration was extended. During this study prolongation, participants had the opportunity to switch to a preferred emicizumab dosing regimen (1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks) in order to provide them the same flexibility as with commercial product.
Cliniques Universitaires St-Luc, Brussels
UZ Leuven Gasthuisberg, Leuven
Royal Brisbane Hospital; Clinical Haematology, Brisbane
Royal Adelaide Hospital; Haematology Clinical Trials, Adelaide
Univ of N Carolina Chapel Hill; Hematology/Oncology, Chapel Hill
Hospital Universitario la Paz; Servicio de Hematologia, Madrid
Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Seville
Hospital Universitario la Fe; Servicio de Hematologia, Valencia
Indiana Hemophilia & Thrombosis center, Indianapolis
University of Michigan, C.S. Mott Children's Hospital, Ann Arbor
University of California Davis, Sacramento
Hokkaido University Hospital, Hokkaido
Nara Medical University Hospital, Nara
National Center for Child Health and Development, Tokyo
Tokyo Medical University Hospital, Tokyo
Instytut Hematologii i Transfuzjologii; Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych, Warsaw
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Wroclaw
Collaborators (1)
Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY