Status:
COMPLETED
Study of Biostate® in Children With Von Willebrand Disease
Lead Sponsor:
CSL Behring
Collaborating Sponsors:
Parexel
Conditions:
Von Willebrand Disease
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE3
Brief Summary
This is an open-label study to investigate the pharmacokinetics (PK), efficacy, and safety of a von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, in children with Von Willebrand disease (VWD) i...
Eligibility Criteria
Inclusion
- Male and female subjects between 0 and \<12 years of age
- Diagnosed with VWD Type 1, 2A, or 3
- Desmopressin acetate (DDAVP) treatment is ineffective, contraindicated, or not available for subject
- von Willebrand factor: ristocetin cofactor (VWF:RCo) is \<20% at screening or the subject has a history of VWF:RCo \<10%
- Evidence of vaccination against hepatitis A and B or presence of antibodies against hepatitis A and B due to either a previous infection or prior immunization
- Written informed consent given
Exclusion
- Active bleeding immediately prior to initial PK period
- Received treatment with DDAVP or a VWF concentrate product for their VWD in the 5 days prior to their first study treatment
- Have received aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) within 7 days of commencing the PK period.
- Known history or suspicion of having VWF or FVIII inhibitors
- 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 other FVIII/VWF concentrates
- Participation in a clinical study or use of an investigational compound in another study in the 3 months preceding study start
- Unwillingness and/or inability to comply with the study requirements
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01213446
Start Date
August 1 2010
End Date
August 1 2013
Last Update
October 3 2017
Active Locations (7)
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1
Study site
Homyel, Belarus, 246040
2
Study site
Minsk, Belarus, 223040
3
Study site
Tbilisi, Georgia, 0179
4
Study site
Bremen, Germany, 28177