Status:
COMPLETED
Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease
Lead Sponsor:
CSL Behring
Collaborating Sponsors:
Parexel
Conditions:
Von Willebrand Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 determ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00941616
Start Date
June 1 2009
End Date
February 1 2012
Last Update
October 3 2017
Active Locations (5)
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1
Study Site
Sofia, Bulgaria
2
Study Site
Warsaw, Poland
3
Study Site
Wroclaw, Poland
4
Study Site
Barnaul, Russia