Severe von Willebrand disease patients undergoing elective major surgery MedDRA version: 9.1 Level: LLT Classification code 10055168 Term: Von Willebrand's factor deficiency
Conditions
Interventions
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 internationa
Sponsors
LFB BIOTECHNOLOGIES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. At least 18 years of age 3. Severe inherited VWF deficiency with baseline VWF:RCo levels =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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. ;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'. | — |
Countries
Belgium, France
Outcome results
None listed