Von Willebrand Disease

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

NCT00941616 | PHASE 2 | INTERVENTIONAL

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

5 Sites

22 Participants

COMPLETED

12 Years

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SUBMIT

Study Site

Sofia,Bulgaria

Study Site

Warsaw,Poland

Study Site

Wroclaw,Poland

Study Site

Barnaul,Russian Federation

Study Site

Lviv,Ukraine,79044

Study Eligibility Criteria

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

Additional Studies

Additional studies can be found at ClinicalTrials.gov