At a glance
ClinicalIndex Comparison Record- ✓Hereditary antithrombin deficiency with personal history of venous thromboembolism
- ✓At least 2 documented plasma AT activity values ≤60%
- ✓Scheduled for elective high-risk surgical procedure, cesarean section, or delivery induction
- ✓Age 18–80 years
- ✕Diagnosis of another hereditary thrombophilic disorder (e.g., Factor V Leiden, Protein S or C deficiency, prothrombin G20210A mutation) or acquired thrombophilic disorder (e.g., lupus anticoagulant)
- ✕Baseline bilateral ultrasound positive for acute DVT or baseline diagnostic testing positive for thromboembolic event other than acute DVT
- ✕Known allergy to goats or goat products
- ✕Prior treatment with investigational drug within 30 days of study start
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Recombinant human antithrombin (rhAT) for Antithrombin III Deficiency. Completed, enrolled 18 participants across 17 sites in 8 countries.
Detailed 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 confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events.
Study Details
Timeline
Interventions
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.