43
Participants
Start Date
June 18, 2020
Primary Completion Date
April 23, 2022
Study Completion Date
April 23, 2022
Wilate
"Produced from the plasma of human donors, Wilate is presented as a powder or solvent for intravenous injection containing normally 500 IU or 1000 IU human VWF and human FVIII per vial. The ratio between VWF ristocetin co-factor activity (VWF:RCo) and FVIII:C is 1:1. The product contains approximately 100 IU/ml human VWF when reconstituted with 5ml/10mL water for injection with 0.1% polysorbate 80.~The specific activity of Wilate is ≥67 IU VWF:RCo/mg protein. The injection or infusion rate should not exceed 2-3mL per minute."
Republican Research Center for Radiation Medicine and Human Ecology, Homyel
Medical Centre Hungarian Defence Forces, Budapest
Debreceni Egyetem Klinikai Központ, Regionális Haemophilia és Thrombophilia Központ, Debrecen
Pediatric Clinic of Haematology and Oncology, Varna
University Hospital Centre Zagreb, Zagreb
Children's Healthcare of Atlanta, Atlanta
"Communal Nonprofit Enterprise Western Ukrainian Specialized Children's Medical Centerof Lviv Regional Council", Lviv
Morosovskaya Children Clinical Hospital, Moscow Health Department, Department of General Hematology with the Pathology of Hemostasis, Moscow
Federal State Budgetary Scientific Institution Kirov Scientific-Research Institute of Hematology and Blood Transfusion of Federal, Kirov
"Specialized Hospital for Active Treatment of Haematological Diseases EAD, Sofia", Sofia
American University of Beirut Medical Center, Beirut
Nini Hospital, Tripoli
Hotel Dieu de France Hospital, Beirut
"State Institution National Children's Specialized Hospital OKHMATDYT of the Ministry of Health of Ukraine, Center of Hemostasis Pathology", Kyiv
Lead Sponsor
Octapharma
INDUSTRY