Clinical Trials Logo

Clinical Trial Summary

Description of the long-term evolution of patients with von Willebrand disease and treated with Voncento® and of the hemostatic efficacy in the prevention and the treatment of non-surgical bleeding episodes and prevention of surgical bleeding during 2 years after patient inclusion.


Clinical Trial Description

Inherited von Willebrand disease (VWD) is considered the most common bleeding disorder. Its prevalence is approximately 1% in the general population but symptomatic patients are rarer (0.01%). It is caused by a partial or total quantitative deficiency (type 1 and type 3) or by a qualitative defect (type 2) of von Willebrand factor (VWF), a large multimeric protein that is required for platelet adhesion and serves as factor VIII (FVIII) carrier. Type 2 VWD is further divided in four subgroups (2A, 2B, 2M, and 2N) that are distinguished according to the nature of the VWF defect. Most patients with type 1 VWD can be treated with the synthetic vasopressin analogue desmopressin (DDAVP; 2-desamino-8-D-arginine vasopressin), whereas patients with type 3 VWD and most patients with type 2 VWD require concentrates containing VWF. Plasma-derived FVIII concentrates, which were initially developed for the treatment of haemophilia, contain large amounts of VWF and are used in patients for whom DDAVP treatment is deemed ineffective or contraindicated. Voncento® (CSL Behring) is a plasma-derived FVIII/VWF concentrate registered in France since 2015 for the treatment and prevention of bleeding events in patients with inherited VWD. OPALE is an observational study describing the use of human coagulation FVIII/VWF concentrate (Voncento®) to treat and prevent bleeding episodes in a French cohort of patients with inherited von Willebrand disease in the real life settings. The aim of the OPALE study is to describe the efficacy and the safety of Voncento® in the prophylaxis and treatment of haemorrhage or surgical bleeding. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04657887
Study type Observational
Source CSL Behring
Contact
Status Completed
Phase
Start date November 23, 2015
Completion date December 31, 2023

See also
  Status Clinical Trial Phase
Withdrawn NCT01651468 - The Effect of the Nutraceutical "Hemofix" on the Coagulation System N/A
Active, not recruiting NCT00555555 - Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients Phase 4
Terminated NCT00178542 - Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle N/A
Completed NCT02552576 - Study of Voncento® in Subjects With Von Willebrand Disease Phase 4
Recruiting NCT02869074 - Molecular and Clinical Profile of Von Willebrand Disease in Spain
Completed NCT01602419 - Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease
Completed NCT01224808 - Extension Study of Biostate in Subjects With Von Willebrand Disease Phase 3
Withdrawn NCT00694785 - A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B Phase 2
Completed NCT00805051 - Acquired Von Willebrand Syndrome in Severe Aortic Stenosis N/A
Completed NCT02246881 - A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A. Phase 3
Completed NCT00168090 - Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD) Phase 4
Withdrawn NCT00630448 - Collection of Blood in Normal Subjects and Subjects With Von Willebrand Disease (VWD) N/A
Terminated NCT00387192 - A Study With OPTIVATE® in People With Von Willebrand Disease Phase 3
Completed NCT02973087 - rVWF IN PROPHYLAXIS Phase 3
Completed NCT01410227 - Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD) Phase 3
Completed NCT01949220 - Willebrand International Non-interventional Global Surveillance
Completed NCT01589848 - Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador N/A
Completed NCT00941616 - Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease Phase 2/Phase 3
Completed NCT00557908 - The Von Willebrand Disease (VWD) International Prophylaxis Study N/A
Active, not recruiting NCT04953884 - Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age Phase 3