An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A

Inclusion Criteria:

PTPs:

- Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII
activity levels < 1%) and who participated in a previous CSL-sponsored clinical study
with rVIII-SingleChain.

- Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A
(FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who
are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.

PUPs:

- Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A
(FVIII activity levels < 1%)

- No prior exposure to any Factor VIII product (with the exception of short-term use of
blood products).

ITI substudy:

- PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.

Exclusion Criteria:

- Known or suspected hypersensitivity to rVIII‑SingleChain or to any excipients of
rVIII‑SingleChain or Chinese hamster ovary (CHO) proteins.

- Currently receiving a therapy not permitted during the study.

- Serum creatinine > 2 x upper limit of normal, alanine aminotransferase or aspartate
aminotransferase > 5 x upper limit of normal at Screening (if specified)

- Any first-order family (eg, siblings) history of FVIII inhibitors

- For PTPs not rolling over directly from a CSL-sponsored clinical study with
rVIII-SingleChain: any history of or current FVIII inhibitors