- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00110513
Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
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 Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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North Gosford, Australia
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Vienna, Austria
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Vancouver, Canada
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Ontario
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Ottawa, Ontario, Canada
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Montpellier, France
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Berlin, Germany
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Alessandria, Italy
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Cambridge, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Nottingham, United Kingdom
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Plymouth, United Kingdom
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Devon
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Exeter, Devon, United Kingdom
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West Sussex
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Chichester, West Sussex, United Kingdom
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Connecticut
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New Haven, Connecticut, United States
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Missouri
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St Louis, Missouri, United States
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New York
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New York, New York, United States
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have hereditary antithrombin deficiency (HD) with a personal history of venous thromboembolic events.
- Have a history of HD that includes 2 or more plasma AT activity values ≤ 60%.
- 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.
- Be at least 18 years of age, not exceeding 80 years of age.
- Have signed an informed consent form.
- 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.
- 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:
- 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).
- 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.
- Patients who have a known allergy to goats or goat products.
- 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.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Recombinant Human Antithrombin (rhAT) Infusion
Intravenous infusion of rhAT.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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.
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During treatment and follow up period of 7 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert C Tait, MD, Glasgow Royal Infirmary
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Hematologic Diseases
- Blood Coagulation Disorders, Inherited
- Genetic Diseases, Inborn
- Blood Protein Disorders
- Blood Coagulation Disorders
- Thrombophilia
- Antithrombin III Deficiency
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protease Inhibitors
- Serine Proteinase Inhibitors
- Anticoagulants
- Antithrombins
- Antithrombin III
Other Study ID Numbers
- GTC AT HD 012-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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