At a glance
ClinicalIndex Comparison Record- ✓Congenital antithrombin deficiency with personal or family history of venous thrombotic events
- ✓Plasma antithrombin activity ≤60% normal documented on 2 or more occasions
- ✓Scheduled for elective procedure at high risk for DVT (surgery, cesarean section, delivery induction, or active labor)
- ✓Age 18–70 years
- ✕Other hereditary thrombophilic disorders (APC resistance, Factor V Leiden, Protein S or C deficiency, prothrombin gene mutation, lupus anticoagulant)
- ✕Scheduled for neurosurgical procedure or open-heart surgery
- ✕Underlying medical condition that could complicate DVT assessment
- ✕Known allergy to goats or goat products
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Recombinant Human Antithrombin (rhAT) for Antithrombin Deficiency, Congenital. Completed, enrolled 14 participants across 11 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.