Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Octapharma
Information provided by (Responsible Party):
Octapharma Identifier:
First received: May 15, 2012
Last updated: October 23, 2015
Last verified: October 2015
This is an observational study, hence there is no study hypothesis

Condition Intervention
Von Willebrand Disease
Other: Patients using wilate as standard of care

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease

Resource links provided by NLM:

Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 2 years per patient ] [ Designated as safety issue: Yes ]
    Document safety and tolerability (Adverse Events, vital signs, tolerability of the infusion) of wilate for prophylaxis and treatment of bleeding in von Willebrand Disease (VWD), including surgeries

Secondary Outcome Measures:
  • Efficacy [ Time Frame: 2 years per patient ] [ Designated as safety issue: No ]
    Document the efficacy of wilate in the treatment of acute bleeding, in the prophylaxis of VWD and in interventional procedures (e.g. minor/major surgery, dental care, invasive diagnostic procedures.

Biospecimen Retention:   Samples Without DNA
Serum Samples

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients using wilate as standard of care treatment
This patient population is being treated with wilate as standard of care treatment
Other: Patients using wilate as standard of care
Patients with von Willebrand Disease using wilate for a period of 2 years.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
VWD patients of any gender, age, or VWD type

Inclusion Criteria:

  • Patients with a diagnosis of von Willebrand Disease who have been prescribed Wilate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01602419

Contact: Sigurd Knaub, PhD

  Show 21 Study Locations
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: Octapharma Identifier: NCT01602419     History of Changes
Other Study ID Numbers: Wil-20
Study First Received: May 15, 2012
Last Updated: October 23, 2015
Health Authority: Germany: PEI (Paul Ehrlich Institute)

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Coagulation Protein Disorders
Genetic Diseases, Inborn
Hematologic Diseases
Hemorrhagic Disorders processed this record on December 01, 2015