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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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17 August 2015 |
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Main ID: |
EUCTR2004-005051-34-BE |
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Date of registration:
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31/05/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLE
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Scientific title:
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Efficacy and safety study of vWF SD-35-DH (WILFACTIN) in children under 6 years of age - NOT APPLICABLE |
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Date of first enrolment:
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18/04/2005 |
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Target sample size:
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15 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-005051-34 |
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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: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Belgium
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
- age < 6 years
- VWF:RCo < 20% (IU/dl) (except type 2N)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
- positive VWF and/or FVIII inhibitors
- platelets < 100 x 10exp9/l (except for type 2B patients)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Von Willebrand disease
Classification code 10047715
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Intervention(s)
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Trade Name: WILFACTIN
Product Name: WILFACTIN
Product Code: VWF SD-35-DH
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: human von Willebrand factor
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 1-
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Primary Outcome(s)
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Primary end point(s): - The biological efficacy of WILFACTIN will be evaluated based on VWF recovery after administration of 100 IU/kg at inclusion of the study and without bleeding ongoing,
- Efficacy of treatment for bleeding episodes will be rated at the end of the episode by the doctor, using the following scale: "excellent", "good", "moderate", "none".
- Efficacy of treatment during surgery will be rated at the end of hospitalisation by the doctor, using the same scale. Blood loss and use of transfusions will be recorded and analysed in comparison to normal subject.
- Efficacy of long-term prophylaxis treatment with vWF SD-35-DH will be judged by the absence of spontaneous bleeding episodes or the clear reduction of haemorrhages.
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Secondary Objective: Secondary objectives : to evaluate the safety, especially the immunological safety, of WILFACTIN in a paediatric population.
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Main Objective: Main objective : to evaluate, in children presenting with inherited von Willebrand factor (VWF) deficiencies, the biological and clinical efficacy of WILFACTIN for the treatment of bleeding episodes and for the prevention of haemorrhages during surgery or invasive procedures when desmopressin is ineffective or contraindicated.
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Secondary ID(s)
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42-73-305 / WIL1-0305
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NOT APPLICABLE
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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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