NCT00056550

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: rEVO Biologics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 : 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.

Conditions

• Antithrombin Deficiency, Congenital

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Human Antithrombin (rhAT)	Biological/Vaccine: Recombinant human antithrombin(rhAT) Phase III clinical trial.

Timeline

• Start date: 2002-12-01
• Primary completion: 2004-02-01
• Completion: 2004-02-01
• First posted: 2003-03-18
• Last updated: 2012-10-16
• Results posted: 2012-10-16

Locations

11 sites across 6 countries: United States, France, Germany, Italy, Sweden, United Kingdom