Ignite Creation Date:
2024-05-06 @ 7:34 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02552576
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2015-09-15
Brief Title:
Study of Voncento in Subjects With Von Willebrand Disease
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
An Open-label Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento in Subjects With Von Willebrand Disease
Status:
COMPLETED
Status Verified Date:
2018-05
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:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-003305-25 | EUDRACT_NUMBER | None | None |