Surveillance of results of long-term prophylactic treatment of von Willebrand disease with Wilate®

Completed

• Conditions: von Willebrand's disease; Haematological Disorders; Other coagulation defects

• Registration Number: ISRCTN25330204
• Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-01
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Male and female patients of any age
2. Suffering from congenital VWD
3. In need of replacement therapy with factor concentrate
4. Patients starting with a prophylactic treatment must have documentation of at least three apparently spontaneous bleeding episodes (any bleeding site and treated with factor concentrate) in the 6 months prior to enrolment
5. Patients switching from a prophylactic treatment with another factor concentrate to prophylaxis with Wilate® should have anamnesis of bleeds with respective documentation in the period of 12 months prior to enrolment

Exclusion Criteria

1. Presence of a bleeding disorder other than VWD
2. History of non-compliance
3. Difficulties in achieving venous access that would prohibit prophylaxis
4. Incapability to follow the requirements of the surveillance, e.g. unable to keep a patient diary

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the bleeding frequency in VWD patients prior to and after introduction of regular prophylactic therapy with the VWF-containing concentrate Wilate®. Outcomes will be measured at baseline, 6 and 12 months after treatment. Please note that the number of days the patients missed school or work, as well as occurred adverse drug reactions are documented when the patient visits his doctor, so outcomes may be measured more frequently than every 6 months.