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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01602419
First Posted: May 21, 2012
Last Update Posted: August 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Octapharma
  Purpose
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 ]
    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 ]
    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
Actual Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
VWD patients of any gender, age, or VWD type
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of von Willebrand Disease who have been prescribed Wilate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602419


  Show 24 Study Locations
Sponsors and Collaborators
Octapharma
  More Information

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01602419     History of Changes
Other Study ID Numbers: Wil-20
First Submitted: May 15, 2012
First Posted: May 21, 2012
Last Update Posted: August 14, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn