Ignite Creation Date:
2024-05-05 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00701545
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2008-06-18
Brief Title:
A Canadian Study to Assess the Safety of Humate-P Ivr Infusion Volume Reduced
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
A Canadian Multi-center Prospective Open-label Observational Pharmacovigilance Study to Assess the Safety of Humate-P Ivr Infusion Volume Reduced in Patients Transitioning From Treatment With Currently Available Humate-P
Status:
COMPLETED
Status Verified Date:
2011-02
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:
As part of CSL Behring Canadas continued commitment to ensuring the safety of the new low volume preparation of Humate-P CSL Behring Canada proposes to conduct a prospective multi-center structured data collection of routine management of patients with von Willebrand disease treated with Humate P ivr in Canada The surveillance will be non-interventional and non-experimental During the observation period the routine medical care of the patient will be documented
It is expected that there will be no difference in the safety and tolerability of Humate-P ivr compared to Humate-P
It is expected that there will be no difference in the safety and tolerability of Humate-P ivr compared to Humate-P
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