NCT04657887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2015

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2020

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

8.1 years

First QC Date

December 1, 2020

Last Update Submit

April 18, 2024

Conditions

Von Willebrand Disease

Keywords

vWDvon Willebrand FactorvWF

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (5)

  • Assessment by the investigator of the hemostatic efficacy of Voncento® during the treatment and the prophylaxis of surgical bleedings and after surgical procedures

    Up to 24 months

  • Number of administrations of Voncento® needed to prevent or treat surgical bleeding episode

    Up to 24 months

  • Total dose of Voncento® (in IU/kg of VWF) needed to prevent or treat surgical bleeding episode

    Up to 24 months

  • Nature and impact of adverse events and in particular serious adverse events, adverse events related to Voncento®

    Up to 24 months

  • Collection of available biological data (ex: FVIII, VWF:Rco, VWF:Ag)

    At baseline and up to 24 months

Interventions

Voncento®BIOLOGICAL

Solution for injection

Also known as: Biostate

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

French cohort of patients with inherited von Willebrand disease treated with Voncento.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

CHU Besançon

Besançon, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Morvan Brest

Brest, France

Location

CHU Lyon

Bron, France

Location

CHU Caen

Caen, France

Location

Hôpital Simone Veil

Eaubonne, France

Location

Hôpital Mignot

Le Chesnay, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

Hôpital Saint-Eloi

Montpellier, France

Location

CHRU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

CHU Lariboisière

Paris, France

Location

Hôpital Cochin

Paris, France

Location

Hôpital Necker

Paris, France

Location

CHU Rennes

Rennes, France

Location

CHU Rouen

Rouen, France

Location

CHU Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

von Willebrand Diseases

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersBlood Platelet DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Study Director

    CSL Behring SA

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 8, 2020

Study Start

November 23, 2015

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

April 19, 2024

Record last verified: 2024-04

Locations

FR(17)