85
Participants
Start Date
May 29, 2006
Primary Completion Date
October 1, 2015
Study Completion Date
December 9, 2015
Recombinant Protein-Free Factor VIII (rAHF-PFM)
"An initial loading dose will be administered intravenously over a period \<= 5 minutes (maximum of infusion rate of 10 mL/minute) within 60 minutes prior to surgery dose in order to maintain a minimum target FVIII level of at least 80% of normal.~CI will start prior to surgery as soon as the loading dose has been administered, at a rate calculated according to a formula provided by the sponsor.~All study product must be administered with a syringe pump running at an infusion rate according to the dosing regimen, but always \>= 0.4 mL/h."
Recombinant Protein-Free Factor VIII (rAHF-PFM)
The treatment schedule for intermittent BI of rAHF-PFM will begin with the administration of the loading dose according to the dose recommendations provided by the sponsor. If required by the hemostatic challenge, additional boluses may be administered after a blood sample for FVIII determination has been drawn. All infusions of rAHF PFM will be given over a period \<= 5 minutes (maximum infusion rate, 10 mL/min).
University Hospital for Internal Medicine I (Hematology/Hemostaseology), Vienna
AMC Medical Research BV, Department of Vascular Medicine, Amsterdam
State Health Centre, National Hemophilia Centre, Budapest
Cliniques Universitaires St. Luc, Haematology Department, Brussels
University Hospital Gasthuisberg, Leuven
University of Debrecen, 2nd Dept of Internal Medicine, Debrecen
Academic Hospital Maastricht, Maastricht
PTE ÁOK I. Internal Medical Clinic, Dept of Hematology, Pécs
University Medical Centre Groningen, Groningen
National Blood Transfusion Institute, Bucharest
Penn State Milton S. Hershey Medical Center, Hershey
Georgetown University, Washington D.C.
"Centro Emofilia e Trombosi Angelo Bianchi Bonomi", Milan
University Hospital MAS, Department for Coagulation Disorders, Malmo
Johns Hopkins Medical Institutions, Baltimore
James Graham Brown Cancer Center, Louisville
Hospital Universitario La Fe, Valencia
Rush Presbyterian St. Lukes, Chicago
Hôpital Edouard Herriot, Lyon
The University of Texas Health Science Center at Houston Medical School, Houston
Department of Clinical & Experimental Medecine, AOU Federico II, Naples
Los Angeles Orthopaedic Hospital, Los Angeles
Hematology Research Center under Russian Academy of Medical Sciences, Department of Reconstructive Orthopedic Surgery for Hemophilia Patients, Moscow
Russian Research Institute of Hematology and Transfusiology, Department of Surgical Hematology and Angiology, Saint Petersburg
Regional Hemophilia Center, Kirov
Tulane University, New Orleans
Brigham and Women´s Hospital, Boston
University Hospitals of Cleveland, Cleveland
Rikshospitalet, Oslo
Krakowskie Centrum Rehabilitacji, Krakow
Instytut Hematologii i Transfuzjologii, Klinika Zaburzeń Hemostazy i Chorób Wewnętrznych, Warsaw
Centro Hospitalar de Coimbra, Coimbra
Hospital Santo António, Porto
"Fundeni Clinical Institute, Clinical Laboratory St. Berceanu Hematology and Bone Marrow Transplantation Department", Bucharest
"Louis Turcanu Emergency Clinical Children´s Hospital, 3rd Pediatrics Department, Hemophilia Center", Timișoara
Hospital Vall d´Hebron, Servei d´Hemofilia, Barcelona
Baxalta Innovations GmbH, now part of Shire
INDUSTRY
Baxalta now part of Shire
INDUSTRY