Condition category
Haematological Disorders
Date applied
18/11/2008
Date assigned
19/11/2008
Last edited
07/04/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes