Ignite Creation Date:
2024-05-05 @ 9:41 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00941616
Status:
COMPLETED
Last Update Posted:
2017-10-03
First Post:
2009-07-15
Brief Title:
Study of a pd VWFFVIII Concentrate Biostate in Subjects With Von Willebrand Disease
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
An Open-label Multi-centre Study to Assess the Pharmacokinetics Efficacy and Safety of Biostate in Subjects With Von Willebrand Disease
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 this study is to assess the pharmacokinetics PK efficacy and safety of Biostate in subjects with Von Willebrand Disease VWD
Pharmacokinetic Component
PK parameters will be determined from a subgroup of subjects Subjects who complete the PK component will subsequently continue in the efficacy component of the study either continuing on a previously established prophylaxis regimen or continuing to receive on-demand treatment with the occurrence of non-surgical bleeding NSB events
Efficacy Component
Three treatment arms are defined for the efficacy component of the study 1 Subjects who are currently being treated on a set prophylaxis regimen with a VWF product at the time of study entry will be enrolled in the Prophylaxis arm 2 Subjects not being treated on a set prophylaxis regimen at the time of study entry who require a VWF product for the treatment of NSB events will be enrolled in the On-demand arm and commence using Biostate in the treatment of NSB events 3 Subjects enrolled in the On-demand arm have the possibility to enter the Cross-over to Prophylaxis arm to receive an additional 12 months of prophylactic treatment
Pharmacokinetic Component
PK parameters will be determined from a subgroup of subjects Subjects who complete the PK component will subsequently continue in the efficacy component of the study either continuing on a previously established prophylaxis regimen or continuing to receive on-demand treatment with the occurrence of non-surgical bleeding NSB events
Efficacy Component
Three treatment arms are defined for the efficacy component of the study 1 Subjects who are currently being treated on a set prophylaxis regimen with a VWF product at the time of study entry will be enrolled in the Prophylaxis arm 2 Subjects not being treated on a set prophylaxis regimen at the time of study entry who require a VWF product for the treatment of NSB events will be enrolled in the On-demand arm and commence using Biostate in the treatment of NSB events 3 Subjects enrolled in the On-demand arm have the possibility to enter the Cross-over to Prophylaxis arm to receive an additional 12 months of prophylactic treatment
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 |
|---|---|---|---|
| 1481 | OTHER | None | None |
| 2008-004922-18 | EUDRACT_NUMBER | CSL Behring | None |