Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056550
Status:
COMPLETED
Last Update Posted:
2012-10-16
First Post:
2003-03-17
Brief Title:
Assess Incidence of Deep Vein ThrombosisDVTFollowing Administration of Recombinant Human Antithrombin rhAT to Hereditary AntithrombinAT Deficient Patients in High Risk Situations
Sponsor:
rEVO Biologics
Organization:
rEVO Biologics
Study Overview
Official Title:
A Study to Assess the Incidence of Deep Vein Thrombosis DVT Following Prophylactic Intravenous Administration of Recombinant Human AntithrombinrhAT to Hereditary Antithrombin AT Deficient Patients in High Risk Situations
Status:
COMPLETED
Status Verified Date:
2012-08
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:
rhAT
Brief Summary:
Patients with hereditary antithrombin AT deficiency are at increased risk of venous thrombosis and pulmonary embolism particularly during certain high risk procedures The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or inducedspontaneous labor and delivery The study will test the safety and efficacy of recombinant human antithrombin rhAT by infusing rhAT prior to during and following the period of risk or surgical procedure
Detailed Description:
Objectives
1 Assess the safety of recombinant antithrombin rhAT in hereditary antithrombin AT deficient patients
2 Assess the incidence of acute deep venous thrombosisDVT alone in patients with hereditary antithrombin AT deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional AT activity at 80 and 120 of normal by prophylactic IV administration of rhAT
3 Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration
1 Assess the safety of recombinant antithrombin rhAT in hereditary antithrombin AT deficient patients
2 Assess the incidence of acute deep venous thrombosisDVT alone in patients with hereditary antithrombin AT deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional AT activity at 80 and 120 of normal by prophylactic IV administration of rhAT
3 Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration
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