Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04657887
Status:
COMPLETED
Last Update Posted:
2024-04-19
First Post:
2020-12-01
Brief Title:
Registry of Patients With Von WilLEbrand Disease Treated With Voncento
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPALE
Brief 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
Detailed 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 001 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 FVIIIVWF 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 FVIIIVWF 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None