Surveillance of Tolerability And Treatment Efficacy of Wilate® in von Willebrand?s disease
Not Applicable
Recruiting
- Conditions
- von Willebrand's diseaseHaematological DisordersVon Willebrand's disease
- Registration Number
- ISRCTN98642570
- Lead Sponsor
- Octapharma GmbH (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of adverse drug reactions. Laboratory parameters relevant to safety when documented
- Secondary Outcome Measures
Name Time Method 1. Percentage of efficacy rating excellent or good in bleeding episodes and surgeries<br>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