A PHASE 3 CLINICAL STUDY TO DETERMINE THE PHARMACOKINETICS, SAFETY AND EFFICACY OF rVWF:rFVIII and rVWF IN THE TREATMENT OF BLEEDING EPISODES IN SUBJECTS DIAGNOSED WITH VON WILLEBRAND DISEASE - Pharmacokinetics, safety and efficacy of rVWF in the treatment of bleeding episodes in VWD

Baxter Innovations GmbH0 sites49 target enrollmentSeptember 26, 2011

Overview

No summary available.

Registry

who.int

Start Date

September 26, 2011

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subject has been diagnosed with:
•Type 1 (VWF:RCo \< 20 IU/dL) or,
•Type 2A (VWF:RCo\< 20 IU/dL), Type 2B (as diagnosed by genotype),
•Type 2N (FVIII:C\<10% and historically documented genetics), Type 2M or,
•Type 3 (VWF:Ag \= 3 IU/dL) or,
•Severe VWD with a history of requiring substitution therapy with von Willebrand factor
•concentrate to control bleeding
•Subject, who participates for the treatment for bleeding episodes, has had a minimum of 1
•documented bleeds (medical history) requiring VWF coagulation factor replacement therapy during the previous12 months prior to enrollment.
•Subject has a Karnofsky score \=60\.

•Subject has been diagnosed with pseudo VWD or another hereditary or acquired coagulation disorder other than VWD (eg qualitative and quantitative platelet disorders or elevated PT/ international normalized ratio \[INR] \>1\.4\).
•Subject has a documented history of a VWF:RCo half\-life of \<6 hours.
•Subject has a history or presence of a VWF inhibitor at screening.
•Subject has a history or presence of a factor VIII (FVIII) inhibitor with a titer \=0\.4 BU (by Nijmegen assay) or \=0\.6 BU (by Bethesda assay).
•Subject has a known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins.
•Subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies.
•Subject has a medical history of a thromboembolic event.
•Subject is HIV positive with an absolute CD4 count \<200/mm3\.
•Subject has been diagnosed with cardiovascular disease (New York Heart Association \[NYHA] classes 1\-4\).
•Subject has an acute illness (eg, influenza, flu\-like syndrome, allergic rhinitis/conjunctivitis, non\-seasonal asthma) at screening.