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Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
This study has been completed.
Sponsored by: GTC Biotherapeutics
Information provided by: GTC Biotherapeutics
ClinicalTrials.gov Identifier: NCT00110513
  Purpose

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
Antithrombin III Deficiency
Drug: Recombinant Human Antithrombin
Phase III

Genetics Home Reference related topics: aceruloplasminemia factor V Leiden thrombophilia hemophilia
Drug Information available for: Antithrombin III Antithrombin Alfa
U.S. FDA Resources
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

Further study details as provided by GTC Biotherapeutics:

Study Start Date: April 2005
Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have hereditary antithrombin deficiency (HD) with a personal history of venous thromboembolic events.
  2. Have a history of HD that includes 2 or more plasma AT activity values ≤ 60%.
  3. Be scheduled to have an elective procedure(s) known to be associated with a high risk for occurrence of a thromboembolic event. This will include non-pregnant surgical patients or pregnant patients scheduled for caesarean section or delivery induction.
  4. Be at least 18 years of age, not exceeding 80 years of age.
  5. Have signed an informed consent form.
  6. Have a negative serum pregnancy test at screening and a negative urine pregnancy test at baseline. This applies only to female non-pregnant surgical patients of childbearing potential.
  7. Are able to comply with the requirements of the study protocol.

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:

  1. Patients who have a diagnosis of Protein S of C deficiency or acquired (lupus anticoagulant) thrombophilic disorder.
  2. Patients who have a baseline bilateral ultrasound positive for acute DVT or baseline diagnostic testing (if required) that is positive for a thromboembolic event other than acute DVT or have signs or symptoms of acute venous thrombosis at baseline.
  3. Patients who have a known allergy to goats or goat products.
  4. Patients who have participated in a study employing a different investigational drug within 30 days of the start of their participation in the current trial.
  5. Patients using fondaparinux sodium or the oral thrombin inhibitor, ximelagatran, or are expected to be treated with fondaparinux sodium or ximelagatran during the study period (up to 7 days after stop of treatment).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110513

Locations
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
Sponsors and Collaborators
GTC Biotherapeutics
  More Information

Additional information on hereditary antithrombin disease  This link exits the ClinicalTrials.gov site

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

Keywords provided by GTC Biotherapeutics:
Antithrombin Deficiency, Congenital or Hereditary
Antithrombin III Deficiency
ATIII
Hereditary Antithrombin Deficiency (HD)

Study placed in the following topic categories:
Antithrombin III Deficiency
Genetic Diseases, Inborn
Blood Protein Disorders
Hematologic Diseases
Thrombophilia
Blood Coagulation Disorders
Hemostatic Disorders
Antithrombin III
Thrombosis

Additional relevant MeSH terms:
Serine Proteinase Inhibitors
Anticoagulants
Blood Coagulation Disorders, Inherited
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009