Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387192
Status:
TERMINATED
Last Update Posted:
2010-03-03
First Post:
2006-10-11
Brief Title:
A Study With OPTIVATE in People With Von Willebrand Disease
Sponsor:
Bio Products Laboratory
Organization:
Bio Products Laboratory
Study Overview
Official Title:
An Open Multi-centre Study in Patients With Von Willebrand Disease to Investigate the Pharmacokinetics Efficacy and Safety of OPTIVATE a High Purity Dual Inactivated Factor VIII and Von Willebrand Factor Concentrate
Status:
TERMINATED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to slow recruitment and a significant delay in reaching the recruitment target
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objective of the study is to assess the pharmacokinetics of OPTIVATE after a single dose of 80 IUkg VWFRCo The secondary objectives of the study are to assess efficacy and safety of OPTIVATE in long-term use over at least 12 months
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