Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease

Inclusion Criteria:

• Diagnosed with VWD

• Desmopressin acetate (DDAVP) treatment is ineffective or contraindicated or not available

• Evidence of vaccination against hepatitis A and B (or presence of antibodies against hepatitis A and B) within 10 years prior to their first dose of Biostate®

• Written informed consent given

Exclusion Criteria (for participation in the PK component):

• Actively bleeding immediately prior to initial PK period

• Have received DDAVP or a VWF product in the 5 days prior to their first dose of study product

• Have Type 2B, 2N or 2M VWD

Exclusion Criteria (for all subjects):

• Requiring a VWF product for a planned surgical procedure at enrolment

• Have received aspirin or other non-steroidal anti-inflammatory drugs within 7 days prior to their first dose of study product

• Known history of, or are suspected to have, VWF or FVIII inhibitors

• Suffering an acute or chronic medical condition, other than VWD, which may affect the conduct of the study

• Known or suspected hypersensitivity or previous evidence of severe side effects to Biostate®, VWF/FVIII concentrates, or human albumin

• Impaired liver function at screening

• Evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit

• Participation in a clinical study or use of an investigational compound in the 3 months preceding the first day of study drug administration, or plans to enter such a study during the study period.

• Females who are pregnant, breast-feeding or who have a positive pregnancy test at screening