Von Willebrand Disease

Study of Biostate® in Children With Von Willebrand Disease

NCT01213446 | PHASE 3 | INTERVENTIONAL

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) in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.

7 Sites

17 Participants

Recruiting

18 Years to 12 Years

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Find closest sites:

SUBMIT

Study site

Homel,Belarus,246040

Study site

Minsk,Belarus,223040

Study site

Tbilisi,Georgia,0179

Study site

Bremen,Germany,28177

Study site

Guatemala,CP,Guatemala,01010

Study site

Beirut,Lebanon

Study Site

Lviv,Ukraine

Study Eligibility Criteria

Inclusion Criteria

* 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 Criteria

* 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

Additional Studies

Additional studies can be found at ClinicalTrials.gov