NL-OMON42081
Withdrawn
Phase 3
A phase 3 prospective, multicenter study to evaluate efficacy and safety of rVWF with or without ADVATE in elective surgical procedures in subjects with severe von Willebrand disease - rVWF in subjects with VWD undergoing surgery
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- extended or excessive bleeding
- Sponsor
- Baxalta Innovations GmbH
- Enrollment
- 2
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who meet ALL of the following criteria are eligible for this study:
- •1\. Diagnosis of severe VWD as listed and elective surgical procedure planned:
- •\- VWD with a history of requiring substitution therapy with von Willebrand factor concentrate
- •to control bleeding.
- •\- Type 1 (VWF:RCo \< 20 IU/dL) or
- •\- Type 2A (as verified by multimer pattern), Type 2B (as diagnosed by genotype), Type 2N
- •(Factor VIII coagulation activity \[FVIII:C] \<10% and historically documented genetics),
- •\- Type 3 (von Willebrand factor antigen \[VWF:Ag] \* 3 IU/dL)
- •2\. If type 3 VWD (VWF:Ag \* 3 IU/dL), subject has a medical history of at least 20 EDs to VWF/FVIII
- •coagulation factor concentrates (including cryoprecipitate or fresh frozen plasma).
Exclusion Criteria
- •Subjects who meet ANY of the following criteria are not eligible for this study:
- •1\. Diagnosis of pseudo VWD or another hereditary or acquired coagulation disorder (eg qualitative and quantitative platelet disorders or elevated PT/ international normalized ratio \[INR] \* 1\.4\)
- •2\. History or presence of a VWF inhibitor at screening
- •3\. History or presence of a factor VIII (FVIII) inhibitor with a titer \* 0\.4 BU (by Nijmegen\-modified
- •Bethesda assay ) or \* 0\.6 BU (by Bethesda assay)
- •4\. Known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins
- •5\. Medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies
- •6\. Medical history of a thromboembolic event
- •7\. HIV positive with an absolute CD4 count \*200/mm3
- •8\. Platelet count \< 100,000/mL
Outcomes
Primary Outcomes
Not specified
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