Status:
COMPLETED
Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery
Lead Sponsor:
rEVO Biologics
Conditions:
Antithrombin III Deficiency
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
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...
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 requirem...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00110513
Start Date
April 1 2005
End Date
July 1 2008
Last Update
August 17 2012
Active Locations (17)
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1
New Haven, Connecticut, United States
2
St Louis, Missouri, United States
3
New York, New York, United States
4
North Gosford, Australia