Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
|Antithrombin III Deficiency||Biological: Recombinant human antithrombin (rhAT)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|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|
- Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Venous Thrombosis (DVT) [ Time Frame: During treatment and follow up period of 7 days ]To assess the incidence of thromboembolic events acute deep venous thrombosis (DVT) and/or thromboembolic events other than acute deep venous thrombosis (DVT) by clinical signs and symptoms of venous thromboembolism (VTE), confirmed by diagnostic assessments.
|Study Start Date:||April 2005|
|Study Completion Date:||July 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Experimental: Recombinant Human Antithrombin (rhAT) Infusion
Intravenous infusion of rhAT.
Biological: Recombinant human antithrombin (rhAT)
Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient will receive an initial intravenous loading dose followed by a continuous intravenous infusion of recombinant human antithrombin (rhAT) that will target and maintain an AT activity that is > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at > 80% and < 120% of normal during the high-risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
Other Name: Recombinant human antithrombin (Tradename: ATryn)
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110513
|United States, Connecticut|
|New Haven, Connecticut, United States|
|United States, Missouri|
|St Louis, Missouri, United States|
|United States, New York|
|New York, New York, United States|
|North Gosford, Australia|
|Ottawa, Ontario, Canada|
|Exeter, Devon, United Kingdom|
|Chichester, West Sussex, United Kingdom|
|Cambridge, United Kingdom|
|Glasgow, United Kingdom|
|London, United Kingdom|
|Nottingham, United Kingdom|
|Plymouth, United Kingdom|
|Principal Investigator:||Robert C Tait, MD||Glasgow Royal Infirmary|