Ignite Creation Date:
2024-05-05 @ 10:58 PM
Last Modification Date:
2024-10-26 @ 10:26 AM
Study NCT ID:
NCT01224808
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2010-06-08
Brief Title:
Extension Study of Biostate in Subjects With Von Willebrand Disease
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
An Open-Label Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate in Paediatric Adolescent and Adult Subjects With Von Willebrand Disease Who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54
Status:
COMPLETED
Status Verified Date:
2017-10
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:
The aim of the Von Willebrand Disease VWD therapy is to treat and prevent bleeding episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or abnormal Von Willebrand Factor VWF andor Factor VIII FVIII levels The long-term efficacy and safety of a VWFFVIII concentrate Biostate will be investigated in children adolescents and adults with VWD in whom treatment with a VWF product is required for prophylactic therapy haemostatic control during surgery or control of a non-surgical spontaneous or traumatic bleeding event
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 |
|---|---|---|---|
| 2009-017301-11 | EUDRACT_NUMBER | None | None |
| 1498 | OTHER | CSL Behring | None |