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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- rEVO Biologics
- Enrollment
- 14
- Locations
- 11
- Primary Endpoint
- Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).
Study Overview
Brief 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.
Detailed Description
Objectives :
- Assess the safety of recombinant antithrombin (rhAT) in hereditary antithrombin (AT) deficient patients.
- 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.
- Clinically assess and determine the relevance of thromboembolic events other than acute DVT to rhAT administration.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Recombinant Human Antithrombin (rhAT) infusion
Loading and continuous infusion dose of rhAT to target and maintain an AT activity level > 80% and < 120% of normal.
Intervention: Recombinant Human Antithrombin (rhAT) (Biological)
Outcomes
Primary Outcomes
Incidence of Thromboembolic Events Acute Deep Venous Thrombosis (DVT) and/or Thromboembolic Events Other Than Acute Deep Vein Thrombosis (DVT).
Time Frame: Baseline, last day of dosing and day 7 (+ or - 1 day)
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).
Secondary Outcomes
- Local Assessment of Thromboembolism by Physical Examination.(30 days after last dose)