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Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) < 6 years with severe hemophilia A (FVIII < 1%)

Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) < 6 years with severe hemophilia A (FVIII < 1%)
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Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT02615691
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Inclusion Criteria:
< 6 years old at the time of screening
previously untreated with < 3 EDs to ADVATE, BAX 855 or FFP any time prior to screening
severe hemophilia A (FVIII < 1%)
Exclusion Criteria:
History or current FVIII inhibitory antibodies (≥ 0.6 BU
Diagnosis of an inherited or acquired hemostatic defect other than hemophilia A
Previously treated with cryo, PRBC, platelets or any type of FVIII concentrate other than ADVATE, BAX 855v or FFP
weight is < 5 kg
Platelet count < 100,000/mL; severe chronic hepatic dysfunction or severe renal impairment
Blood Disorders
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Study Locations

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Location
Hershey, PA