Contact information
Type
Scientific
Primary contact
Ms Jennifer Feddern
ORCID ID
Contact details
Octapharma GmbH
Langenfeld
40764
Germany
jennifer.feddern@octapharma.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
WIL-15
Study information
Scientific title
Acronym
Wilate-SET
Study hypothesis
The efficacy of Wilate® in clinical practice is comparable to the efficacy in clinical trial patients.
As of 07/05/2011 the anticipated end date for this trial has been extended from 31/07/2009 to 31/07/2012
Ethics approval
As the procedures during this observational study do not interfere with the patient's usual treatment and monitoring of treatment, this study is not regarded as a clinical study as defined by EU Directive 2001/20/EC. Therefore approval by an Independent Ethical Committee as an Institutional Review Board is not required.
Study design
Non-interventional, observational, open, prospective, multi-centre study
Primary study design
Observational
Secondary study design
Multi-centre
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Von Willebrand's disease
Intervention
Documentation of details of diagnosis and bleeding frequency at entry, details of bleeding episodes and surgical procedures during 2-year individual observation period. Documentation of details of each injection including assessment of efficacy and tolerability at a 4-point verbal rating scale. Documentation of relevant laboratory assessments if performed.
Intervention type
Drug
Phase
Not Specified
Drug names
Wilate®
Primary outcome measures
Percentage of efficacy assessments with rating "excellent/good".
Secondary outcome measures
Percentage of tolerability assessments with rating "excellent/good".
Overall trial start date
01/02/2005
Overall trial end date
31/07/2012
Reason abandoned
Eligibility
Participant inclusion criteria
Patients (any age and gender) suffering from hereditary or acquired Von Willebrand's disease requiring von Willebrand factor (VWF)/coagulation factor eight (FVIII) concentrate.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
At least 30 patients
Participant exclusion criteria
Does not comply with the above inclusion criteria
Recruitment start date
01/02/2005
Recruitment end date
31/07/2012
Locations
Countries of recruitment
Germany
Trial participating centre
Octapharma GmbH
Langenfeld
40764
Germany
Sponsor information
Organisation
Octapharma GmbH (Germany)
Sponsor details
Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany
VWS@octapharma.de
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Octapharma GmbH (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary