Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate - WILCOME
- Conditions
- von Willebrand disease
- Registration Number
- EUCTR2008-000795-24-SE
- Lead Sponsor
- Octapharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
Male and female patients of any age suffering from congenital VWD in need of replacement therapy with factor concentrate.
Patients starting with a prophylactic treatment for the first time must have documentation of at least 3 apparently spontaneous bleeding episodes (any bleeding site and treated with VWF concentrate) in the 6 months prior to enrolment.
or
Patients switching from a prophylactic treatment with another VWF/FVIII concentrate to prophylaxis with Wilate should have anamnesis of bleeds with respective documentation in the period of 12 months prior to enrolment.
Written informed consent from patient or patient’s parents.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Presence of a bleeding disorder other than VWD.
History of non-compliance.
Difficulties in achieving venous access.
Incapability to follow the requirements of the surveillance, e.g. unable to keep a patient diary.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Bleeding frequency during prophylactic Wilate treatment in von Willebrand disease;Secondary Objective: QoL<br>joint morbidity;Primary end point(s): Bleeding frequency under prophylactic treatment with Wilate
- Secondary Outcome Measures
Name Time Method