A Study Investigating Treatment Factor X in People With Factor X Deficiency

Inclusion Criteria:

- Written informed consent given, or for subjects aged 12-17 years, have given written
assent and whose parent/guardian has given written informed consent

- At least 12 years of age at dtae of written informed consent

- Have hereditary severe or moderate FX deficiency

- Currently treated with Fresh Frozen Plasma FFP, Prothrombin Complex Concentrate PCC
or factor IX/X concentrate

- Must have a minimum of one spontaneous or menorrhagic bleed in the last 12 months
which required treatment of FFP, PCC or factor IX/X concentrate. Newly diagnosed
subjects who present at the hospital with a bleed may be included

- Must have had at least 7 days, and ideally 10-14 days, since an infusion of either
FFP, PCC or factor IX/X concentrate at Baseline Visit

- Females of child bearing potential must have a negative result on a HCG based
pregnancy test. If they are or become sexually active, they must practise
contraception by using a method of proven reliability for the duration of the study

Exclusion Criteria:

- Have a history of inhibitor development to FX or a positive result at the Screening
Visit

- Bleeding at the appointment for the PK assessment

- Subjects who have thrombocytopenia

- Have clinically significant liver disease

- Known to have other coagulopathy or thrombophilia

- Have known or suspected hypersensitivity to the investigational medicinal product or
its excipients

- Have abused chemicals or drugs within the past 12 months

- Have a history of unreliability or non-cooperation

- Participating or have taken part in another trial within the last 30 days, with the
exception of BPL FX surgery study - Protocol Ten03. In such cases, subjects should
have completed their End of Study Visit either before or on the day of Screening
Visit for this study

- Female subjects who are pregnant or lactating

- Subjects planning greater than 4 weeks absence from the locality of the
Investigational site, between the screening visit and the repeat PK assessment