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)
Male
Female
Patients
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
Notice
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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