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Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00110513
Recruitment Status : Completed
First Posted : May 11, 2005
Results First Posted : May 11, 2012
Last Update Posted : August 17, 2012
Information provided by (Responsible Party):
rEVO Biologics

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 induced/spontaneous labor and delivery, and/or 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.

Condition or disease Intervention/treatment Phase
Antithrombin III Deficiency Biological: Recombinant human antithrombin (rhAT) Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : April 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 for DVT. 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 were allowed entry into the study.

Exclusion Criteria:

  1. Patients who have a diagnosis of another hereditary thrombophilic disorder (e.g. activated protein C(APC) resistance/Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation (G20210A), 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.
  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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00110513

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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
Vienna, Austria
Canada, Ontario
Ottawa, Ontario, Canada
Vancouver, Canada
Montpellier, France
Berlin, Germany
Alessandria, Italy
United Kingdom
Exeter, Devon, United Kingdom
Chichester, West Sussex, United Kingdom
Cambridge, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Nottingham, United Kingdom
Plymouth, United Kingdom
Sponsors and Collaborators
rEVO Biologics
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Principal Investigator: Robert C Tait, MD Glasgow Royal Infirmary

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: rEVO Biologics Identifier: NCT00110513     History of Changes
Other Study ID Numbers: GTC AT HD 012-04
First Posted: May 11, 2005    Key Record Dates
Results First Posted: May 11, 2012
Last Update Posted: August 17, 2012
Last Verified: August 2012
Keywords provided by rEVO Biologics:
Antithrombin Deficiency, Congenital or Hereditary
Antithrombin III Deficiency
Hereditary Antithrombin Deficiency (HD)
Additional relevant MeSH terms:
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Antithrombin III Deficiency
Antithrombin III
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Blood Protein Disorders
Genetic Diseases, Inborn
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action