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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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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-004943-31-SE |
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Date of registration:
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12/09/2007 |
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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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The VWD International Prophylaxis (VIP) Study - VIP study
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Scientific title:
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The VWD International Prophylaxis (VIP) Study - VIP study |
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Date of first enrolment:
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03/10/2007 |
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Target sample size:
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200 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004943-31 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Dose escalation cohort trial
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Dose and dose intervals
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Phase:
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Countries of recruitment
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Sweden
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Type 1 and type 2 von Willebrand disease
=20% RCo and/or =20% FVIII
DDAVP non-responsive
Bleeding indication criteria are met
Type 3 bleeding indication criteria are met
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Acquired von Willebrand disease
History of inhibitory antibodies to VWF
Already on prophylaxis
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Severe form of von Willebrand disease
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Intervention(s)
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Trade Name: Haemate-P, Wilate
The present study is not restricted to any specific product.
Product Name: VWD factor VIII concentrate
Product Code: Factor VIII
Pharmaceutical Form: Intravenous infusion
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Primary Outcome(s)
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Main Objective: Study prophylaxis in von Willebrand disease
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Secondary Objective: Feasibility, adverse events, quality of life, health economy
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Primary end point(s): Bleeding pattern in the year prior to prophylaxis compared to bleeding pattern during prophylaxis.
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Secondary ID(s)
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21 March, 2007
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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