Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.
Condition: Antithrombin Deficiency, Congenital
MeSH terms: Thrombosis; Venous Thrombosis; Antithrombin III Deficiency
Intervention: Recombinant Human Antithrombin (rhAT)
Intervention description: Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.
Intervention MeSH terms: Antithrombins; Antithrombin III
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Antithrombin Deficiency, Congenital; Antithrombin III Deficiency

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have congenital AT deficiency with a personal or family history of venous thrombotic
             events.

          -  Have a history of congenital AT deficiency that includes 2 or more plasma AT activity
             levels of ≤ 60% normal.

          -  Are scheduled to have an elective procedure known to be associated with a high risk
             for occurrence of Deep Venous Thrombosis (DVT). This will include surgical patients or
             pregnant patients scheduled for cesarean section or delivery induction. In addition,
             hospitalized pregnant HD patients in active labor will be allowed into the study.

          -  Are at least 18 years of age, not exceeding 70 years of age.

          -  Have signed an informed consent form.

          -  Have a negative serum pregnancy test at screening and negative urine pregnancy test at
             baseline. This only applies to female surgical patients (not scheduled for cesarean
             section) of childbearing potential.

          -  Are able to comply with the requirements of the study protocol.

        Exclusion Criteria:

          -  Patients who have a diagnosis of hereditary APC resistance, Factor V Leiden, Protein S
             or C deficiency, prothrombin gene mutation (G20210A), or acquired (lupus
             anticoagulant) thrombophilic disorder.

          -  Patients who are scheduled for a neurosurgical procedure or open-heart surgery.

          -  Patients who have an underlying medical condition, which in the opinion of the
             investigator, could complicate the assessment of the incidence of DVT.

          -  Patients who have a known allergy to goats or goat products.

          -  Patients who have participated in a study employing an investigational drug within 30
             days of the start of their participation in the current trial.

          -  Patients using fondaparinux sodium, or are expected to be treated with fondaparinux
             sodium during the study period.