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ISRCTN
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ISRCTN98642570
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DOI
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10.1186/ISRCTN98642570
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Surveillance of Tolerability And Treatment Efficacy of Wilate® in von Willebrand’s disease
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Scientific title
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Surveillance of Tolerability And Treatment Efficacy of Wilate® in von Willebrand’s disease: An observational study
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Acronym
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Wilate-STATE
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Serial number at source
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WIL-25
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Study hypothesis
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Wilate 500/1000 is safe and efficacious for treatment of von Willebrand's disease in clincial practice.
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Lay summary
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Background and study aims
Patients with von Willebrand disease (a bleeding disorder that affects your blood's ability to clot) may require substitution with a coagulation factor concentrate like Wilate. In this study, data about the treatment with Wilate will be collected for safety surveillance and efficacy evaluations.
Who can participate?
All patients with von Willebrands disease in need for replacement therapy who’s doctor had first decided to use Wilate and then to participate in the study can be included.
What does the study involve?
The treatment with Wilate will be the same as prescribed by the doctor without the study – no additional interventions are required. Careful documentation of therapy by the doctor or in case of home treatment by the patient is necessary.
What are the possible benefits and risks of participating?
All information collected in the course of the treatment with Wilate will add knowledge on the use of Wilate and treatment of the von Willebrand disease under routine conditions.
There are no risks arising from participation.
Where is the study run from?
The study will take place in several haemophilia centres in Germany.
When is the study starting and how long is it expected to run for?
The study starts in June 2012 and is planned for a duration of 5 years.
Who is funding the study?
The study is beeing funded by Octapharma, the company that produces and distributes Wilate.
Who is the main contact?
Jennifer Feddern
jenniferfeddern@octapharma.de
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Ethics approval
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Ethics Committee of Medical Faculty of Johann Wolfgang Goethe University Frankfurt/Main Germany, November 2012
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Study design
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Observational open prospective multi-centre study
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Countries of recruitment
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Germany
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Disease/condition/study domain
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von Willebrand's disease
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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28/06/2012
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Anticipated end date
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30/05/2017
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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120
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Interventions
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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 of bleeding episodes and information regarding possible surgical interventions. The efficacy will be assessed according to a 4-point verbal rating scale. Suspected adverse drug reactions (”side effects”) will be documented. The observation time depends on the clinical needs of the patient, e.g. from a few days in case Wilate is required only to cover a surgery or until study end in case of prophylactic treatment.
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Primary outcome measure(s)
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Rate of adverse drug reactions. Laboratory parameters relevant to safety when documented
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Secondary outcome measure(s)
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1. Percentatge 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.
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Sources of funding
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Octapharma GmbH (Germany)
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Trial website
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Publications
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Contact name
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Ms
Jennifer
Feddern
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Address
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Elisabeth-Selbert-Str. 11
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City/town
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Langenfeld
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Zip/Postcode
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40764
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Country
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Germany
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Tel
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+49 (0)2173 917233
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Fax
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+49 (0)2173 917211
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Email
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jennifer.feddern@octapharma.de
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Sponsor
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Octapharma GmbH (Germany)
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Address
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Elisabeth-Selbert-Str. 11
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City/town
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Langenfeld
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Zip/Postcode
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40764
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Country
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Germany
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Tel
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+49 (0)2173 917100
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Fax
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+49 (0)2173 917211
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Email
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VWS@octapharma.de
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Sponsor website:
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http://www.octapharma-biopharmaceuticals.com
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Date applied
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13/09/2012
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Last edited
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05/12/2012
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Date ISRCTN assigned
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05/12/2012
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