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Surveillance of Tolerability And Treatment Efficacy of Wilate® in von Willebrand?s disease

Surveillance of Tolerability And Treatment Efficacy of Wilate® in von Willebrand?s disease: an observational study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN98642570
Enrollment
120
Registered
2012-12-05
Start date
2012-07-28
Completion date
Unknown
Last updated
2017-06-05

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

Conditions

von Willebrand's disease Haematological Disorders Von Willebrand's disease

Interventions

For this non-interventional study, details of the patient history and the current treatment with Wilate will carefully be recorded. This included information on of injections, duration and intensity o

Sponsors

Octapharma GmbH (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Rate of adverse drug reactions. Laboratory parameters relevant to safety when documented

Secondary

MeasureTime 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

Outcome results

None listed

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