Collection of data on the use of a VWF/FVIII concentrate (wilate®) in all clinical applications in von Willebrand disease

Non-interventional study to capture data on the use of a VWF/FVIII concentrate (wilate®) in all clinical settings of von Willebrand disease including health-related quality of life

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN11568655

Enrollment

120

Registered

2022-02-09

Start date

2020-06-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Von Willebrand disease (VWD) Haematological Disorders Von Willebrand disease

Interventions

wilate-NEWS is an non-interventional study for which the routine treatment of VWD patients on prophylaxis or on-demand treatment is documented. All treatments occurring with wilate, any bleeding episo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patient has congenital or acquired Von Willebrand disease (VWD) and requires injections with VWF-containing concentrate (wilate) 2. With a positive bleeding history, other possible causes have been excluded

Exclusion criteria

Exclusion criteria: 1. Patients with known contraindications as specified in the Summary of Product Characteristics (SPC) 2. The patient could actually be treated with DDAVP (Desmopressin Acetate) 3. The patient has a von Willebrand factor activity over 70% and there are no findings manifesting the VWD diagnosis

Design outcomes

Primary

Measure	Time frame
Percentage of haemostatic efficacy ratings of "excellent" and "good" for bleeding treatments and surgical interventions, as well as the annual bleeding rate in prophylactically treated patients, measured at the end of the study. According to the study protocol, efficacy is rated by the treating physicians for every bleeding event treated with Wilate and surgery respectively treated with Wilate on a 4-point Likert scale (excellent, good, moderate, none).	—

Measure

Time frame

Percentage of haemostatic efficacy ratings of "excellent" and "good" for bleeding treatments and surgical interventions, as well as the annual bleeding rate in prophylactically treated patients, measured at the end of the study. According to the study protocol, efficacy is rated by the treating physicians for every bleeding event treated with Wilate and surgery respectively treated with Wilate on a 4-point Likert scale (excellent, good, moderate, none).

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Secondary

Measure	Time frame
1. Safety assessed using the number of patients experiencing at least one adverse drug reaction (ADR) measured at the end of the study 2. Calculation of the VWF dose/kg body weight per injection and calculation of the duration of use in the different treatment options (prophylaxis, bleeding treatment, surgical intervention), depending on the VWD type or severity of bleeding or intervention, at the end of the study 3. Health-related quality of life measured optionally half-yearly using SF-36 during treatment with Wilate, including a comparison between types of VWD and between female and male patients - as far as case numbers allow 4. Comparison of joint status determined optionally half-yearly using the Haemophilia Joint Health Score (HJHS) and annualised bleeding rate, taking into account the treatment mode as well as the VWD type (as far as the case numbers allow), at the end of the study 5. PBAC (Pictorial Blood Assessment Chart) scores in relation to treatment regimen and dosages at the end of the study	—

Measure

Time frame

1. Safety assessed using the number of patients experiencing at least one adverse drug reaction (ADR) measured at the end of the study 2. Calculation of the VWF dose/kg body weight per injection and calculation of the duration of use in the different treatment options (prophylaxis, bleeding treatment, surgical intervention), depending on the VWD type or severity of bleeding or intervention, at the end of the study 3. Health-related quality of life measured optionally half-yearly using SF-36 during treatment with Wilate, including a comparison between types of VWD and between female and male patients - as far as case numbers allow 4. Comparison of joint status determined optionally half-yearly using the Haemophilia Joint Health Score (HJHS) and annualised bleeding rate, taking into account the treatment mode as well as the VWD type (as far as the case numbers allow), at the end of the study 5. PBAC (Pictorial Blood Assessment Chart) scores in relation to treatment regimen and dosages at the end of the study

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026