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This study is a retrospective chart review study and will collect data on real world use of vonicog alfa (Recombinant Von Willebrand Factor [rVWF]). Von Willebrand disease (VWD) is the most common inherited bleeding disorder. rVWF is approved in Europe and UK to treat bleeding and to treat and prevent bleeding during surgeries in adults in 2018.
This study will review and collect information on the treatment and bleed prevention of adult persons with inherited VWD with rVWF in UK. These data were already collected as a part of the routine care.
The main aims of this study are to describe the use of rVWF in on-demand treatment of bleeding and the prevention of treatment and treatment of bleeding during surgeries. Other aims are to describe bleedings and their treatment as well as any surgeries before and after first treatment with rVWF and to gather information on the use of healthcare resources (such as hospital visits, emergency room visits, etc.).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants diagnosed With Congenital VWD | Participants who have been diagnosed with congenital VWD and prescribed rVWF within the index date range (defined as the first administration of rVWF and must fall between 1st October 2020 and 30th June 2022) will be assessed using data obtained from medical records to evaluate the treatment outcome of rVWF in real-world clinical practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Intervention | Other | This is a non-interventional study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Bleeding Episodes Treated with rVWF Between the Index Date and Following 12 Months | Bleeding episodes will be assessed based on categories of overall and annualized, type, severity, location, bleed frequency, bleed type/location and bleed severity. | From index date up to 12 months |
| Number of Surgical Procedures Between the Index Date and Following 12 Months | Surgical procedures included surgery type, severity, category (emergency or elective). Data on the participants use of rVWF in the pre-, intra- and post-operative setting during the period between the index date and the following 12 months, will be stratified by VWD type, surgery type, severity, location, or treatment rationale. | From index date up to 12 months |
| Number of Participants with Surgery Outcomes (Success, Failure, Complications) Between the Index Date and Following 12 Months | Surgery outcomes (success, failure, complications) will be reported. | From index date up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With VWD-Related Healthcare Resource Utilization (HRU) | HRU will include bleeding-related hospitalization rates, outpatient visits, accident and emergency visits. | Up to 24 months |
| Number of Participants With Surgery Related Costs By Type |
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Inclusion criteria:
Adults (aged 18 or over at time of first administration of rVWF) who have provided informed consent and used rVWF within its licensed indication.
Participants who have been diagnosed with congenital von Willebrand disease.
Confirmed instance of
Exclusion criteria:
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Participants who have been diagnosed with congenital VWD and were prescribed rVWF in UK.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Birmingham | Birmingham | B15 2GW | United Kingdom | |||
| Leeds Teaching Hospital |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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Takeda does not provide access to Individual Participant Data when a study is in a very limited (small) study population due to participant privacy concerns such as potential reidentification of study participants.
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Surgery related costs by type will include length of stay in intensive care unit (ICU), rVWF consumption, factor VIII (FVIII) consumption, VWD treatment consumption, laboratory tests and examinations. |
| Up to 24 months |
| Number of Participants With Bleeding Episodes Treated With rVWF | Bleeding episodes will be reported based on type, severity, location, treatment, and outcomes, of all recorded bleeds within 12 months prior to and 12 months following the first administration of rVWF. | Up to 24 months |
| Number of Surgical Procedures | Surgical procedures will be reported based on surgery type (orthopaedic, gastro-intestinal, dental, etc), severity (major, minor), category (emergency or elective) treatment duration and outcomes, of all recorded surgeries within 12 months prior to and 12 months following the first administration of rVWF. | Up to 24 months |
| Number of Participants with Surgery Outcomes (Success, Failure, Complications) | Surgery outcomes (success, failure, complications) based on average number of post-operative bleeds will be reported. | Up to 24 months |
| Leeds |
| LS9 7TF |
| United Kingdom |
| Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Royal Free London | London | NW3 2QG | United Kingdom |
| Imperial College Healthcare | London | W2 1NY | United Kingdom |
| Manchester University | Manchester | M13 9WL | United Kingdom |
| Oxford University Hospital | Oxford | OX3 9DU | United Kingdom |
| ID | Term |
|---|---|
| D014842 | von Willebrand Diseases |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D001791 | Blood Platelet Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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