Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00168077
Status:
COMPLETED
Last Update Posted:
2011-02-11
First Post:
2005-09-12
Brief Title:
Prothrombin Complex Concentrate for Anticoagulant Reversal
Sponsor:
CSL Behring
Organization:
CSL Behring
Study Overview
Official Title:
Efficacy and Tolerance of BERIPLEX PN in Subjects With Acquired Deficiency of Coagulation Factors II VII IX and X Due to Oral Anticoagulation
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:
Patients on oral anticoagulants need rapid reversal of the anticoagulant effect in case of acute bleeding or emergency surgery Prothrombin Complex Concentrates are known to provide a fast reversal of the anticoagulant effect with several advantages over alternatives like vitamin K or FFPThe planned clinical Phase III study is designed to provide clinically relevant data on efficacy and safety
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