Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110513
Status:
COMPLETED
Last Update Posted:
2012-08-17
First Post:
2005-05-10
Brief Title:
Recombinant Human Antithrombin rhAT in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Sponsor:
rEVO Biologics
Organization:
rEVO Biologics
Study Overview
Official Title:
A Multicenter Multinational Study to Assess the Safety and Efficacy of Antithrombin Alfa in Hereditary Antithrombin AT Deficient Patients in High-Risk Situations for Thrombosis
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:
None
Brief Summary:
Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism particularly during certain high risk procedures The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or inducedspontaneous labor and delivery andor caesarean section The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin rhAT to patients with hereditary antithrombin AT deficiency in situations usually associated with a high risk for thromboembolic events
Detailed Description:
GTC Biotherapeutics established clinical trial sites in Europe Canada Australia Austria and Canada GTC Biotherapeutics provided an international clinical team to support site registration requirements once a patient was identified for treatment GTC Biotherapeutics also provided consultation to help evaluate patient eligibility
In September 2006 GTC Biotherapeutics modified exclusion criteria 1 below to allow for the participation of previously excluded patients with the hereditary thrombophilic disorders Factor V Leiden and prothrombin gene mutation G20210A
In September 2006 GTC Biotherapeutics modified exclusion criteria 1 below to allow for the participation of previously excluded patients with the hereditary thrombophilic disorders Factor V Leiden and prothrombin gene mutation G20210A
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