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Clinical trial

Observational Registry of Patients With Von WilLEbrand Disease Treated With Voncento®

ID
Name
OPALE study
Description
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.
Trial arms
Trial start
2015-11-23
Estimated PCD
2023-12-31
Trial end
2023-12-31
Status
Completed
Treatment
Voncento®
Solution for injection
Other names:
Biostate
Size
135
Primary endpoint
Global assessment by the patient and the investigator of the hemostatic efficacy of Voncento® in the management of non-surgical bleeding episodes
Up to 24 months
Number of non-surgical bleeding episodes per year
Up to 24 months
Number of administrations of Voncento® needed to treat a non-surgical bleeding episode and for the long term prophylaxis
Up to 24 months
Total dose of Voncento® (in IU/kg of VWF) needed to treat a non-surgical bleeding episode and for the long term prophylaxis
Up to 24 months
Eligibility criteria
Inclusion Criteria: * Patients suffering from constitutional von Willebrand disease for whom Desmopressin treatment is deemed ineffective or contraindicated * Patients suffering from von Willebrand disease and being treated or having been treated with Voncento® for the treatment of surgical and non-surgical bleeding episodes, the prophylaxis of surgical and non-surgical bleedings * Patients with no history or suspicion of inhibitors (judged on previous efficacy) Exclusion Criteria: * Refusal of the patient or the patient's legal representative to take part in the study; * Existence of a contraindication to the use of Voncento® treatment
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 135, 'type': 'ACTUAL'}}
Updated at
2024-04-19

1 organization

1 product

1 indication

Organization
CSL Behring
Product
Voncento®
Indication
von Willebrand disease