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.