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Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery (WONDERS)

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. Identifier: NCT01365546
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : March 9, 2015
Last Update Posted : March 9, 2015
Information provided by (Responsible Party):

Brief Summary:
Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.

Condition or disease Intervention/treatment Phase
Prevent Bleeding in Major Surgery Biological: human VWF/FVIII concentrate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective, Open-Label, Multi-Center, Phase III CLinical Study to Investigate the Efficacy and Safety of Human Factor VWF/FVIII Concentrate (Wilate) in Subjects With Inherited Von Willebrand Disease Who Undergo Surgical Procedures
Study Start Date : June 2011
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: human VWF/FVIII concentrate Biological: human VWF/FVIII concentrate
intravenous infusion. Dose based on subject's individual invivo-recovery

Primary Outcome Measures :
  1. Overall Hemostatic Efficacy (Success or Failure) of Wilate, Based on the Intra-operative Assessment of the Surgeon and the Post-operative Assessment by the Investigator Using a 4-point Ordinal Efficacy Scale. [ Time Frame: 30 Days ]
    Efficacy of Wilate in surgical procedures was assessed intra-operatively by the surgeon and post-operatively by the investigator. The IDMC additionally conducted an independent adjudication of all hemostatic efficacy results ('secondary adjudication') and adjudicated the surgeons'/investigators' assessments of the intra- and post-operative assessments where there were discrepancies between the two assessments ('primary adjudication'). It was specified in the SAP that the study will be terminated early and success claimed if the two-sided 98.75% confidence interval (CI) for the overall success rate excludes and is greater than 0.60 (equivalent to 25 or more successes out of the 30 procedures).

Secondary Outcome Measures :
  1. Assessment of Intra-operative Hemostatic Efficacy [ Time Frame: 1 Day ]
    The efficacy of Wilate during surgical procedures was assessed by a 4-point ordinal efficacy scale by the surgeon at the end of the surgical procedure and took the predicted versus actual blood loss and transfusion requirements into consideration. Outcome measure 1 takes the results of outcome measure 2 and 3 into consideration and is an overall assessment covering intra- and post-operative efficacy.

  2. Post-operative Efficacy Assessment [ Time Frame: up to 30 days ]
    Post-operative efficacy was assessed by the investigator, covering the time period from the end of the procedure up to 24 hours following the last infusion of study medication. This assessment took the post-operative bleeding and oozing into consideration

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.

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with congenital VWD (von Willebrand Disease)
  • Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure

Exclusion Criteria:

  • Known coagulation disorder other than VWD
  • Known history of, or suspected VWF or FVIII inhibitors
  • Subjects with hepatic liver disease
  • Known or suspected hypersensitivity or previous evidence of severe side effects to wilate or other VWF/FVIII concentrates
  • Pregnant women in the first 20 weeks of gestation

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 identifier (NCT number): NCT01365546

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United States, Indiana
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States, 46260
United States, North Carolina
UNC-CH Comprehensive Hemophilia Center
Chapel Hill, North Carolina, United States, 27599
United States, Wisconsin
Blood Center of Wisconsin
Milwaukee, Wisconsin, United States, 53201
SHAT Joan Pavel
Sofia, Bulgaria, 1233
Christian Medical College
Vellore, Tamil Nadu, India, 632004
Sahyadri Specialty Hospital
Pune, India, 411004
Azienda Ospedaliero Universitaria Careggi
Florence, Italy, 50133
Granda Ospedale Maggiore Policlinico
Milano, Italy, 20122
ULSS6 Vicenza Ematologia
Vicenza, Italy, 36100
Sultan Quaboos University Hospital
Muscat, Oman, PC123
Instytut Hematologii i Transfuzjologii
Warsaw, Poland, 0.-776
Fundeni Clinical Institute
Bucharest, Romania, 022328
Louis Turcanu Childrens Emergency Hospital
Timisoara, Romania, 300011
South Africa
Hemophilia Comprehensive Care Center
Johannesburg, South Africa, 2193
Ege University
Izmir, Turkey, 35100
Sponsors and Collaborators

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Responsible Party: Octapharma Identifier: NCT01365546    
Other Study ID Numbers: Wil-24
First Posted: June 3, 2011    Key Record Dates
Results First Posted: March 9, 2015
Last Update Posted: March 9, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Von Willebrand Diseases
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Blood Platelet Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII