Patients with hereditary antithrombin (AT) 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. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.
Objectives : 1. Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT) deficient patients. 2. Assess the incidence of acute deep venous thrombosis(DVT) alone in patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events after increasing and targeting functional AT activity at \>80% and \< 120% of normal by prophylactic IV administration of rhAT. 3. Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
14
Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
Unnamed facility
Marietta, Georgia, United States
Unnamed facility
Charleston, South Carolina, United States
Unnamed facility
Paris, France
Unnamed facility
Toulouse, France
Unnamed facility
Berlin, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Mannheim, Germany
Unnamed facility
Milan, Italy
Unnamed facility
Stockholm, Sweden
Unnamed facility
Bristol, United Kingdom
...and 1 more locations
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).
Observation for clinical signs and symptoms of thromboembolic events are evaluated for acute deep vein thrombosis (DVT) using duplex ultrasonography and/or other imaging tests to confirm clinical signs/symptoms. Duplex ultrasonography was performed at baseline, last day of dosing and day 7 (+ or -1 day).
Time frame: Baseline, last day of dosing and day 7 (+ or - 1 day)
Local Assessment of Thromboembolism by Physical Examination.
The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.
Time frame: 30 days after last dose
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