von Willebrand disease
Conditions
Interventions
Trade Name: Wilate
Pharmaceutical Form: Powder and solvent for solution for injection
Concentration unit: IU international unit(s)
Sponsors
Octapharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Bleeding frequency during prophylactic Wilate treatment in von Willebrand disease;Secondary Objective: QoL joint morbidity;Primary end point(s): Bleeding frequency under prophylactic treatment with Wilate | — |
Countries
Sweden
Outcome results
None listed