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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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4 April 2022 |
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Main ID: |
EUCTR2007-004116-32-FR |
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Date of registration:
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12/03/2009 |
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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 WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA
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Scientific title:
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EFFICACY AND SAFETY STUDY OF WILFACTIN ADMINISTERED BY CONTINUOUS INFUSION IN PATIENTS WITH SEVERE VON WILLEBRAND DISEASE UNDERGOING MAJOR SURGICAL PROCEDURES - NA |
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Date of first enrolment:
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03/12/2008 |
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Target sample size:
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18 |
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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:2007-004116-32 |
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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:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Written informed consent
2. At least 18 years of age
3. Severe inherited VWF deficiency with baseline VWF:RCo levels <0.15-0.20 IU/ml (15-20%)
4. Clinical and laboratory diagnosis of VWD that can be expected to show no haemostatic response to desmopressin
5. Elective major surgery
In the study, major surgery in severe VWD patients (at least 6 type 3 patients will be included) is defined as surgery requiring at least 6 days of replacement therapy from among the following:
o orthopaedic surgery
o abdominal surgery
o gynaecological surgery
o urological surgery
o neurological surgery
Are the trial subjects under 18? no
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:
1. Present or past inhibitor activity against FVIII and/or VWF:RCo
2. Laboratory evidence of abnormal haemostasis other than VWD
3. Platelet count < 100 x 109/l (except for type 2B VWD)
4. Chronic liver disease or AST and ALT > 2.5 times the upper limit of the normal range
5. Creatinine clearance calculated according to Cockroft -Gault formula <60 ml/min
6. Personal history of thromboembolic events
7. History of severe reaction to any component of the IMP
8. Participation in another clinical study involving an investigational drug within the past 30 days or on going participation in another clinical study (except if the patient is participating in another WILFACTIN study)
9. Any other condition that the Investigator believes could interfere with the intent of the study or would not be in the best interest of the patient
10. Pregnant or lactating woman or woman of childbearing age not using a medically acceptable method of birth control during the study
11. Problematic venous access
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 von Willebrand disease patients undergoing elective major surgery
MedDRA version: 9.1
Level: LLT
Classification code 10055168
Term: Von Willebrand's factor deficiency
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Intervention(s)
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Trade Name: WILFACTIN
Product Name: WILFACTIN
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: 100-
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Primary Outcome(s)
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Main Objective: The primary objective is to evaluate the efficacy of continuous infusion of WILFACTIN for the prevention of perioperative bleeding in patients with severe von Willebrand Disease undergoing elective major surgery.
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Secondary Objective: The secondary objectives are to evaluate the:
• biological efficacy of continuous infusion of WILFACTIN for achievement of target VWF:RCo levels and maintenance of the pharmacodynamic effect documented by haemostatic FVIII:C levels.
• safety of continuous infusion of WILFACTIN.
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Primary end point(s): The primary efficacy endpoint will be the haematologist’s overall assessment on D7 of haemostasis during and following surgery for at least 6 days (144 hours).
Haemostasis will be rated using the following 4-point scale:
•. 'excellent': bleeding similar to that expected in a normal subject,
•. 'good': mild excessive bleeding,
•. 'moderate': moderate but controlled excessive bleeding,
•. 'none': severe, uncontrolled bleeding.
The physician’s rating will be based on the following parameters:
• blood loss (comparison of predicted and actual volumes),
• haemoglobin levels and transfusion requirements,
• assessment of haemostatic efficacy on D0 by the surgeon using the same
4-point scale,
• daily medical examination of the surgical site.
A successful procedure is defined as a procedure for which the haemostasis assessment is rated 'excellent' or 'good'.
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Secondary ID(s)
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Protocol WIL1-0609
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 03/12/2008
Contact:
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