von Willebrand's disease Haematological Disorders Von Willebrand's disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient suffers from hereditary or acquired von Willebrand's disease and is in need for replacement of coagulation concentrate containing von Willebrand factor (VWF) 2. When bleeding history is positive, other causes were excluded
Exclusion criteria
Exclusion criteria: 1. The patient could actually be treated with DDAVP (Desmopressin Acetate) 2. The patient has a von Willebrand factor activity over 70 % and there are no findings manifesting the von Willebrand (VWD) diagnosis like 2.1. Bleeding pattern compliant with VWD 2.2. Positive family history 2.3. Mutation analysis 2.4. Multimer pattern
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse drug reactions. Laboratory parameters relevant to safety when documented | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percentage of efficacy rating "excellent" or "good" in bleeding episodes and surgeries 2. Bleeding frequency in prophylactically treated patients and - if available - course of laboratory parameters indicating anemia. Comparison of efficacy results with precursor study with Wilate 450/900 when feasible | — |
Countries
Germany