- * 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
Von Willebrand Disease
The aim of this study is to assess the pharmacokinetics (PK), efficacy, and safety of Biostate® in subjects with Von Willebrand Disease (VWD). Pharmacokinetic Component: PK parameters will be determined from a subgroup of subjects. Subjects who complete the PK component will subsequently continue in the efficacy component of the study, either continuing on a previously established prophylaxis regimen or continuing to receive on-demand treatment with the occurrence of non-surgical bleeding (NSB) events. Efficacy Component: Three treatment arms are defined for the efficacy component of the study. (1) Subjects who are currently being treated on a set prophylaxis regimen with a VWF product at the time of study entry will be enrolled in the "Prophylaxis" arm. (2) Subjects not being treated on a set prophylaxis regimen at the time of study entry who require a VWF product for the treatment of NSB events will be enrolled in the "On-demand" arm and commence using Biostate in the treatment o
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Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov