NCT02552576

Study of Voncento® in Subjects With Von Willebrand Disease

An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects With Von Willebrand Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a multi-centre, open-label, single-arm, phase 4, post-marketing study to further investigate the efficacy and safety of Voncento in subjects with Von Willebrand Disease (VWD) in whom treatment with a Von Willebrand Factor (VWF) product is required as on-demand therapy, for prophylactic therapy, or during surgery. Subjects will be treated with Voncento either as an on-demand regimen (eg, to treat a non-surgical spontaneous or traumatic bleeding event) or prevention regimen (eg, to prevent an anticipated bleeding event) at a dose prescribed by the Investigator in accordance with the Voncento Summary of Product Characteristics (SmPC), or with a prophylaxis regimen (regular treatment with Voncento at a frequency of 1-3 times per week). Voncento will also be given to prevent and treat any surgical bleeding events.

Conditions

• Von Willebrand Disease

Interventions

Type	Name	Description
BIOLOGICAL	Voncento	Human coagulation VWF / coagulation factor VIII (FVIII) complex concentrate

Timeline

• Start date: 2015-10-05
• Primary completion: 2018-02-15
• Completion: 2018-02-15
• First posted: 2015-09-17
• Last updated: 2018-05-16

Locations

12 sites across 5 countries: Austria, Germany, Greece, Poland, United Kingdom