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Sponsored by: |
GTC Biotherapeutics |
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Information provided by: | GTC Biotherapeutics |
ClinicalTrials.gov Identifier: | NCT00110513 |
Patients with hereditary antithrombin 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 induced/spontaneous labor and delivery, and/or C-section. The study will assess 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.
Condition | Intervention | Phase |
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Antithrombin III Deficiency |
Drug: Recombinant Human Antithrombin |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Study Start Date: | April 2005 |
GTC will establish a clinical trial site in any location in Europe, Canada and the US depending on the needs of the physician and the patient. To provide this flexibility, GTC has an international clinical team to support site registration requirements once a patient has been identified for treatment. We also provide consultation to help evaluate patient eligibility.
In September 2006, GTC 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).
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
In addition, hospitalized pregnant HD patients in active labor and eligible HD patients previously treated with rhAT will be allowed entry into the study.
Exclusion Criteria:
Australia | |
North Gosford, Australia | |
Canada, Ontario | |
Ottawa, Ontario, Canada | |
France | |
Montpellier, France | |
Germany | |
Berlin, Germany | |
Italy | |
Alessandria, Italy | |
United Kingdom | |
Glasgow, United Kingdom | |
Cambridge, United Kingdom | |
London, United Kingdom | |
Plymouth, United Kingdom | |
Nottingham, United Kingdom |
Study ID Numbers: | GTC AT HD 012-04 |
Study First Received: | May 10, 2005 |
Last Updated: | February 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00110513 |
Health Authority: | United States: Food and Drug Administration |
Antithrombin Deficiency, Congenital or Hereditary Antithrombin III Deficiency ATIII Hereditary Antithrombin Deficiency (HD) |
Antithrombin III Deficiency Genetic Diseases, Inborn Blood Protein Disorders Hematologic Diseases Thrombophilia |
Blood Coagulation Disorders Hemostatic Disorders Antithrombin III Thrombosis |
Serine Proteinase Inhibitors Anticoagulants Blood Coagulation Disorders, Inherited Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Hematologic Agents Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |