N/A
N=265
Type 3 Von Willebrand International Registries Inhibitor Prospective Study
Type 3 Von Willebrand's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02460458 ↗Enrolled (actual)
265
Serious AEs
1.9%
Results posted
Apr 2016
Primary outcome: Primary: Centralized Factor VIII (FVIII) Procoagulant Activity (FVIII:C) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis — 2.42 IU/dL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Von Willebrand Factor (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Fondazione Angelo Bianchi Bonomi
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Centralized Factor VIII (FVIII) Procoagulant Activity (FVIII:C) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis |
2.42 | — |
| PRIMARY Centralized Von Willebrand Factor Antigen (VWF:Ag) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis |
1.01 | — |
| PRIMARY Centralized Factor VIII (FVIII) Amidolytic Activity (FVIII:Am) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis |
1.54 | — |
| PRIMARY Centralized Factor VIII (FVIII) Antigen (FVIII:Ag) Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis |
3.63 | — |
| PRIMARY Centralized Von Willebrand Factor (VWF) Multimer Analysis for Type 3 Von Willebrand's Disease (VWD3) Diagnosis |
174; 15; 54 | — |
| PRIMARY Centralized Von Willebrand Factor (VWF) Propeptide Laboratory Test for Type 3 Von Willebrand's Disease (VWD3) Diagnosis |
6.44 | — |
| PRIMARY Centralized Molecular Type 3 Von Willebrand's Disease (VWD3) Diagnosis Through DNA Analysis |
219; 12 | — |
| PRIMARY Record of Bleeding Episodes |
713 | — |
| PRIMARY Adverse Events |
47 | — |
| PRIMARY Type of Von Willebrand Factor / Factor VIII (VWF/FVIII)-Containing Concentrates in Use |
1; 1; 33; 5; 1 | — |
| SECONDARY Patients Experiencing Allergic Reactions During Use of Von Willebrand Factor (VWF)-Containing Concentrates |
41 | — |
| SECONDARY Number of Participants With Previous Use of Blood Products |
24; 123; 10; 1 | — |
| SECONDARY Number of Patients With Available Local Laboratory Test for Anti-Von Willebrand Factor (Anti-VWF) Antibodies |
4 | — |
| SECONDARY Local Laboratory Tests for Type 3 Von Willebrand's Disease (VWD3) Diagnosis (Composite) |
265 | — |
Summary
International Registries and Prospective Study on Type 3 Von Willebrand's Disease (VWD3), aimed to assess number, types and risk factors for bleeding and the efficacy and safety of plasma-derived and/or recombinant Von Willebrand Factor (VWF) concentrates used to treat VWD patients.
Eligibility Criteria
Inclusion Criteria
- Male and female of any age, including infants, children, adolescent and adults
- Informed Consent obtained (parents should sign for patients < 18 y.o.)
- Previous Diagnosis of VWD3 (VWF Antigen: undetectable or <5 U/dL)
- Detailed information on inherited pattern, history of bleeding, previous exposure to blood products
- Availability of plasma and DNA samples
Exclusion Criteria
- VWD3 patients who may not be available for follow-up
Data sourced from ClinicalTrials.gov (NCT02460458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.