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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01365546 |
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Date of registration:
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27/05/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
WONDERS |
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Scientific title:
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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 |
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Date of first enrolment:
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June 2011 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01365546 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Countries of recruitment
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Bulgaria
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India
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Italy
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Oman
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Poland
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Romania
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South Africa
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Turkey
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United States
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Key inclusion & exclusion criteria
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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
Age minimum:
6 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Prevent Bleeding in Major Surgery
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Intervention(s)
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Biological: human VWF/FVIII concentrate
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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Assessment of Intra-operative Hemostatic Efficacy
[Time Frame: 1 Day]
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Post-operative Efficacy Assessment
[Time Frame: up to 30 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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