EUCTR2010-024108-84-AT
Active, not recruiting
Not Applicable
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
DrugsADVATE (rAHF-PFM)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Baxter Innovations GmbH
- Enrollment
- 49
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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