Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
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Study Matches
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%)
< 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