Detail of the clinical trial

Title of the trial Phase 3, prospective, randomized, multi-center clinical study comparing the safety and efficacy of BAX 855 following PK-guided prophylaxis targeting two different FVIII trough levels in subjects with severe Hemophilia A
EudraCT number 2014-005477-37
Protocol number 261303
Sponsor Baxalta Innovations GmbH, Industriestrasse 67, A-1221 Vienna, Austria
Indications Hematology
Diagnosis Hemophilia A
Population in clinical trial Adolescents (12-17 years)
Adults (18-65 years)
Year of receiving the request to Institute (SÚKL) 2015
Date of approval by Institute (SÚKL) 18.12.2015
Date of approval by EC 17.2.2016
Date of initiation CT in ČR nezahájena v ČR
Date of ending CT in ČR 30.3.2017
Sites Fakultní nemocnice Brno,Oddělení klinické hematologie,Jihlavská 20, 625 00 Brno
Fakultní nemocnice Plzeň ,Ústav klinické biochemie a hematologie ,Alej Svobody 80 , 304 60 Plzeň

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