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

NCT ID: NCT01602419

Last Updated: 2021-01-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2018-04-30

Brief Summary

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This is an observational study, hence there is no study hypothesis

Detailed Description

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Conditions

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Von Willebrand Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients using Wilate as standard of care treatment

This patient population is being treated with Wilate as standard of care treatment

Patients using Wilate as standard of care

Intervention Type OTHER

Patients with von Willebrand Disease using Wilate for a period of 2 years.

Interventions

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Patients using Wilate as standard of care

Patients with von Willebrand Disease using Wilate for a period of 2 years.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with a diagnosis of von Willebrand Disease who have been prescribed Wilate
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Octapharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Los Angeles Biomedical Research Institute

Torrance, California, United States

Site Status

Nicklaus Children's Hospital

Miami, Florida, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Fundación de la Hemofilia de Salta

Salta, , Argentina

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

St. John Regional Hospital

Saint John, New Brunswick, Canada

Site Status

Eastern Regional Health Authority

St. John's, Newfoundland and Labrador, Canada

Site Status

McMaster University

Hamilton, Ontario, Canada

Site Status

Queens University

Kingston, Ontario, Canada

Site Status

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

Site Status

St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status

University Hospital Ostrava

Ostrava-Poruba, , Czechia

Site Status

Werlhof-Institut

Hanover, , Germany

Site Status

Centro Hospitalar Cova da Beira

Covilha, , Portugal

Site Status

Hospital Universitario de Burgos

Burgos, , Spain

Site Status

Hospital San Pedro de Alcantara

Cáceres, , Spain

Site Status

Hospital Fundacion Jiminez Diaz

Madrid, , Spain

Site Status

Skåne University Hospital

Malmo, , Sweden

Site Status

Great Ormond Street Hospital for Children

London, , United Kingdom

Site Status

Hospital Pereira Rossell

Montevideo, , Uruguay

Site Status

Sanatorio Americano

Montevideo, , Uruguay

Site Status

Countries

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United States Argentina Canada Czechia Germany Portugal Spain Sweden United Kingdom Uruguay

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Wil-20

Identifier Type: -

Identifier Source: org_study_id

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