An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A

Inclusion Criteria:

- Diagnosis of severe hemophilia A defined as <1% FVIII:C documented in medical
records.

- Males between 18 and 65 years of age (Parts 1 and 2).

- Males between 12 and 65 years of age (Part 3).

- Subjects who have received or are currently receiving FVIII products (plasma-derived
and/or recombinant FVIII) and have had >150 exposure days (EDs) with a FVIII product

- Written informed consent for study participation obtained before undergoing any study
specific procedures.

Exclusion Criteria:

- Any history of or current FVIII inhibitors

- Any first order family history of FVIII inhibitors

- Use of an Investigational Medicinal Product within 30 days prior to the first CSL627
administration.

- Administration of any cryoprecipitate, whole blood or plasma within 30 days prior to
administration of CSL627 or reference product.

- Known hypersensitivity (allergic reaction or anaphylaxis) to any FVIII product or
hamster protein.

- Any known congenital or acquired coagulation disorder other than congenital FVIII
deficiency.

- Platelet count < 100,000/µL at screening.

- HIV positive subjects with a CD4 count < 200/mm3, in their medical history or at
screening if available results are older than one year. (HIV positive subjects may
participate in the study and antiviral therapy are permitted, at the discretion of
the Investigator).

- Subject currently receiving IV immunomodulating agents such as immunoglobulin or
chronic systemic corticosteroid treatment.

- Subject with serum aspartate aminotransferase (AST) or serum alanine aminotransferase
(ALT) values > 5 times (x) the upper limit of normal (ULN) at Screening.

- Subjects with serum creatinine values > 2 x ULN at Screening.

- Evidence of thrombosis, including deep vein thrombosis, stroke, pulmonary embolism,
myocardial infarction and arterial embolus within 3 months prior to Day 1.

- Experienced life-threatening bleeding episode or had major surgery or an orthopedic
surgical procedure during the 3 months prior to Day 1.