Antithrombin Deficiency, Congenital Clinical Trial
Official title:
A Study to Assess the Incidence of Deep Vein Thrombosis (DVT) Following Prophylactic Intravenous Administration of Recombinant Human Antithrombin(rhAT) to Hereditary Antithrombin (AT) Deficient Patients in High Risk Situations.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention