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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