Condition category
Haematological Disorders
Date applied
13/09/2012
Date assigned
05/12/2012
Last edited
05/12/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jennifer Feddern

ORCID ID

Contact details

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany
+49 (0)2173 917233
jennifer.feddern@octapharma.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

WIL-25

Study information

Scientific title

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

Acronym

Wilate-STATE

Study hypothesis

Wilate 500/1000 is safe and efficacious for treatment of von Willebrand's disease in clincial practice.

Ethics approval

Ethics Committee of Medical Faculty of Johann Wolfgang Goethe University Frankfurt/Main Germany, November 2012

Study design

Observational open prospective multi-centre study

Primary study design

Observational

Secondary study design

Other

Trial setting

Hospitals

Trial type

Screening

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

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Wilate®

Primary outcome measures

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

Secondary outcome measures

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.

Overall trial start date

28/06/2012

Overall trial end date

30/05/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

28/06/2012

Recruitment end date

30/05/2017

Locations

Countries of recruitment

Germany

Trial participating centre

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany

Sponsor information

Organisation

Octapharma GmbH (Germany)

Sponsor details

Elisabeth-Selbert-Str. 11
Langenfeld
40764
Germany
+49 (0)2173 917100
VWS@octapharma.de

Sponsor type

Industry

Website

http://www.octapharma-biopharmaceuticals.com

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