The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)
1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
Specialized Hospital for Active Treatment "Joan Pavel"
Sofia, Bulgaria
Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults
Berlin, Germany
UKGM Uniklinikum Giessen & Marburg
Giessen, Germany
Harrison Clinical Research Deutschland
Serious and non-serious AEs
Time frame: 4 weeks after infusion with BAX 855 and ADVATE
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Munich, Germany
Nara Medical University Hospital
Nara, Japan
Tokyo Medical University Hospital
Tokyo, Japan
Quintiles Drug Research Unit at Guy´s Hospital
London, United Kingdom
Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary
Manchester, United Kingdom