Clinical Trial: Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Patien

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 Summary:

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.

Sponsor: rEVO Biologics

Current Primary Outcome: 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).


Original Primary Outcome:

Current Secondary Outcome: Local Assessment of Thromboembolism by Physical Examination. [ Time Frame: 30 days after last dose ]

The investigators evaluated patients for any clinical signs of thromboembolism by physical examination.


Original Secondary Outcome:

Information By: rEVO Biologics

Dates:
Date Received: March 17, 2003
Date Started: December 2002
Date Completion:
Last Updated: September 17, 2012
Last Verified: August 2012