BAX 826 Dose-Escalation Safety Study
BAX 826 Dose-Escalation Safety Study
1. To assess tolerability and safety of BAX 826 after a single infusion in previously
 treated patients (PTPs) with severe hemophilia A

 2. To determine the pharmacokinetic (PK) parameters of BAX 826 compared to ADVATE

 3. To evaluate immunogenicity of polysialic acid linked to Factor VIII (FVIII)
Inclusion Criteria:

 1. Previously treated male participants aged 18 to 65 years (inclusive) at the time of
 screening

 2. Diagnosis of severe hemophilia A (Factor VIII level <1%)

 3. Previously treated with FVIII concentrates for ≥150 documented Exposure Days (EDs)

 4. Karnofsky performance score of ≥60

 5. Human immunodeficiency virus negative (HIV-); or HIV+ with stable disease

 6. Hepatitis C virus negative (HCV-); or HCV+ with chronic stable hepatitis as assessed
 by the investigator

 7. Able to understand and have provided written informed consent including signature on
 an informed consent form (ICF) approved by an ethics committee (EC)

 8. Have provided written authorization for use and disclosure of protected health
 information

 9. Agree to abide by the study schedule and to return for the required assessments

 10. Willing and able to comply with the requirements of the protocol

 Exclusion Criteria:

 1. Detectable FVIII inhibitor at screening, with a titer ≥0.6 Bethesda Unit (BU)

 2. Documented history of FVIII inhibitors with a titer ≥0.4 BU at any time prior to
 screening

 3. Known clinical hypersensitivity towards mouse or hamster proteins or to polysialic
 acid (PSA)

 4. Scheduled elective surgery during study participation

 5. Severe chronic hepatic dysfunction

 6. Severe renal impairment

 7. Currently receiving, or has recently received (less than 3 months prior to study
 participation), or is scheduled to receive during the course of the study, other
 PSA-ylated drugs

 8. Have received another investigational drug within 30 days prior to study entry and/or
 is scheduled to receive additional investigational drug during the course of the study
 in the context of another investigational drug study

 9. Diagnosis of an inherited or acquired hemostatic defect other than hemophilia A

 10. Currently receiving, or scheduled to receive during the course of the study, an
 immune-modulating drug other than antiretroviral chemotherapy

 11. Has a clinically significant medical, psychiatric or cognitive illness or recreational
 drug/alcohol use that, in the opinion of the investigator, would affect the safety or
 compliance of the participant during the study

 12. Is a family member or employee of the investigator